190 Regulatory Submissions jobs in the United Kingdom

Senior Pharmaceutical Regulatory Affairs Specialist

M1 1AA Manchester, North West £60000 Annually WhatJobs

Posted 2 days ago

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Job Description

full-time
Our client is a rapidly growing pharmaceutical company seeking a dedicated Senior Pharmaceutical Regulatory Affairs Specialist to join their team. In this vital role, you will be responsible for navigating the complex landscape of pharmaceutical regulations and ensuring that our products meet all necessary compliance requirements for market entry and maintenance. You will play a key part in preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance to cross-functional teams. The ideal candidate will possess a deep understanding of global regulatory requirements and a proven ability to manage regulatory projects efficiently.

Key Responsibilities:
  • Prepare, review, and submit regulatory submissions (e.g., MAAs, NDAs, variations) to health authorities worldwide.
  • Develop and implement regulatory strategies to support product development and commercialisation.
  • Ensure compliance with all relevant national and international pharmaceutical regulations and guidelines (e.g., EMA, FDA, MHRA).
  • Liaise with regulatory agencies, manage communications, and respond to queries.
  • Conduct regulatory intelligence monitoring to stay informed of changes in the regulatory landscape.
  • Provide regulatory support to product lifecycle management, including post-approval changes and renewals.
  • Collaborate with R&D, manufacturing, quality assurance, and marketing teams to align regulatory activities with business objectives.
  • Review promotional materials and labelling for regulatory compliance.
  • Contribute to the development of regulatory policies and procedures.
  • Participate in regulatory inspections and audits.
Required Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  • Minimum of 7 years of experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of regulatory requirements in key markets (e.g., Europe, USA).
  • Proven experience in preparing and submitting complex regulatory dossiers.
  • Strong understanding of drug development processes.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Proficiency in regulatory information management systems.
  • Ability to manage multiple projects simultaneously and meet tight deadlines.
  • Strong analytical and problem-solving skills.
  • Team-oriented with the ability to work effectively in a collaborative environment.
This role is based at our client's offices in Manchester, Greater Manchester, UK . If you are a skilled and experienced Regulatory Affairs Specialist looking to make a significant contribution to the pharmaceutical industry, we encourage you to apply.
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Senior Pharmaceutical Regulatory Affairs Manager

PL1 1RR Plymouth, South West £80000 Annually WhatJobs

Posted 4 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company dedicated to improving global health, is seeking a Senior Pharmaceutical Regulatory Affairs Manager to join their remote-based team. This pivotal role will oversee the regulatory strategy and submission process for a diverse portfolio of pharmaceutical products. You will be responsible for ensuring compliance with global regulatory requirements, guiding product development teams, and securing timely approvals from health authorities worldwide. Key responsibilities include developing and implementing regulatory strategies for product registration and lifecycle management; preparing and submitting regulatory dossiers (e.g., INDs, NDAs, MAAs) to various health agencies (e.g., FDA, EMA); serving as the primary point of contact with regulatory authorities; interpreting and advising on complex regulatory guidelines and policies; conducting regulatory intelligence activities to stay ahead of evolving requirements; managing post-approval changes and submissions; collaborating with R&D, clinical, manufacturing, and quality assurance departments; and mentoring junior regulatory affairs professionals. The ideal candidate will possess extensive experience in pharmaceutical regulatory affairs, with a deep understanding of global regulatory frameworks. Proven success in leading regulatory submissions and interactions with health authorities is essential. Excellent communication, analytical, and problem-solving skills are critical for this complex, remote role. You will be empowered to make critical decisions and contribute significantly to bringing life-saving medicines to market. Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 7 years of experience in pharmaceutical regulatory affairs.
  • Proven track record of successful regulatory submissions (e.g., IND, NDA, MAA) to major health authorities.
  • In-depth knowledge of ICH guidelines and regional regulatory requirements.
  • Experience in regulatory strategy development and lifecycle management.
  • Excellent written and verbal communication skills.
  • Strong analytical and critical thinking abilities.
  • Ability to manage multiple projects and work effectively in a remote environment.
This is an exceptional opportunity for a regulatory affairs expert to play a critical role in advancing pharmaceutical innovation and patient access.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist

AB10 1QE Aberdeen, Scotland £80000 Annually WhatJobs

Posted 6 days ago

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Job Description

full-time
Our client, a global pharmaceutical leader, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote role. This position is critical for ensuring compliance with all relevant regulatory requirements for drug development and marketing. You will be responsible for developing and implementing regulatory strategies, preparing and submitting regulatory documentation, and liaising with health authorities worldwide. The ideal candidate possesses extensive knowledge of global pharmaceutical regulations, excellent analytical skills, and a meticulous attention to detail. This is a fully remote opportunity, allowing you to contribute to groundbreaking pharmaceutical advancements from anywhere.

Key Responsibilities:
  • Develop and execute regulatory affairs strategies for new and existing pharmaceutical products.
  • Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to global health authorities.
  • Serve as the primary point of contact for regulatory agencies, managing communications and responses.
  • Interpret and advise on complex global regulatory requirements and guidelines.
  • Collaborate cross-functionally with R&D, Clinical Operations, Quality Assurance, and Commercial teams to ensure alignment on regulatory submissions.
  • Maintain an up-to-date understanding of the regulatory landscape and emerging trends.
  • Conduct regulatory intelligence activities and provide strategic recommendations.
  • Manage post-approval regulatory activities, including variations, renewals, and safety reporting.
  • Ensure compliance with all applicable pharmaceutical laws and regulations.
  • Contribute to the development and implementation of departmental SOPs and processes.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  • Minimum of 7 years of experience in pharmaceutical regulatory affairs.
  • Proven track record of successful regulatory submissions and approvals in major markets (e.g., FDA, EMA, PMDA).
  • In-depth knowledge of global pharmaceutical regulatory guidelines and submission requirements.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Exceptional written and verbal communication skills, with strong attention to detail.
  • Ability to manage multiple complex projects simultaneously and meet strict deadlines.
  • Experience working in a remote environment and collaborating effectively with global teams.
  • Proficiency in regulatory information management systems is a plus.

This is a significant opportunity to play a key role in bringing life-saving medicines to patients worldwide, working remotely and supporting our client’s strategic goals within the pharmaceutical industry, impactful for their operations around Aberdeen, Scotland, UK .
This advertiser has chosen not to accept applicants from your region.

Remote Senior Pharmaceutical Regulatory Affairs Specialist

OX1 2HQ Oxford, South East £65000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a globally recognized pharmaceutical company committed to advancing human health, is seeking a highly experienced Remote Senior Pharmaceutical Regulatory Affairs Specialist. This is a fully remote position, offering an exceptional opportunity to contribute to bringing life-saving medicines to market from anywhere in the UK. You will be responsible for navigating the complex regulatory landscape, ensuring compliance with global health authority requirements, and managing regulatory submissions for a diverse portfolio of pharmaceutical products. If you possess a deep understanding of regulatory affairs within the pharmaceutical industry and excel in independent, remote work, this role is an ideal fit. Your expertise will be crucial in shaping regulatory strategies and ensuring timely approvals.

Responsibilities:
  • Develop and execute regulatory strategies for product development and lifecycle management.
  • Prepare, review, and submit regulatory documentation to global health authorities (e.g., EMA, FDA).
  • Interpret and apply regulatory guidelines and regulations to ensure compliance.
  • Liaise with health authorities regarding submissions, inquiries, and inspections.
  • Collaborate with internal teams (e.g., R&D, Clinical Operations, Quality Assurance) to ensure regulatory requirements are met.
  • Assess the regulatory impact of proposed changes to products and manufacturing processes.
  • Manage post-approval regulatory activities, including variations, renewals, and compliance monitoring.
  • Provide regulatory input for clinical trial applications and study protocols.
  • Stay current with evolving regulatory requirements and industry best practices.
  • Contribute to the training and development of regulatory affairs personnel.
Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree (MSc, PhD, PharmD) preferred.
  • Minimum of 5-7 years of progressive experience in pharmaceutical regulatory affairs.
  • Proven track record of successfully preparing and submitting various regulatory dossiers (e.g., CTD, IND, NDA).
  • In-depth knowledge of global regulatory submission requirements and processes.
  • Familiarity with GMP, GCP, and GLP principles.
  • Excellent written and verbal communication skills, with meticulous attention to detail.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently, manage multiple projects, and meet tight deadlines in a remote setting.
  • Proficiency in regulatory information management systems and relevant software.
  • Experience with specific therapeutic areas is a plus.
This is a unique opportunity to join a leading pharmaceutical company and significantly impact patient access to essential medications, all while enjoying the flexibility of a remote role.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist - Remote

SO15 1AA Southampton, South East £70000 Annually WhatJobs

Posted 4 days ago

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Job Description

full-time
Our client, a leading pharmaceutical innovator, is actively seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dynamic team. This is a fully remote position, offering the flexibility to work from anywhere while contributing to global drug development. You will be responsible for developing and executing regulatory strategies for product approvals across various international markets. This includes preparing and submitting regulatory dossiers (e.g., CTD, IND, NDA), liaising with health authorities, and ensuring ongoing compliance with all relevant regulations and guidelines. The ideal candidate will possess a deep understanding of the pharmaceutical regulatory landscape, including GMP, GCP, and GLP, as well as specific regional requirements (e.g., EMA, FDA, PMDA). Your expertise will be crucial in navigating complex regulatory pathways, providing strategic advice to project teams, and managing the lifecycle of regulatory submissions. You will also be involved in post-approval activities, including variations and renewals. This is a pivotal role for a dedicated professional looking to make a significant impact on bringing life-changing therapies to patients worldwide, all within a supportive and collaborative remote work environment.

Key Responsibilities:
  • Develop and implement global regulatory strategies for pharmaceutical product development and approval.
  • Prepare, review, and submit regulatory dossiers to health authorities worldwide (e.g., FDA, EMA, MHRA).
  • Liaise effectively with regulatory agencies, responding to queries and managing submissions.
  • Ensure compliance with all applicable regulations, guidelines, and standards (GMP, GCP, GLP).
  • Provide strategic regulatory guidance and support to cross-functional project teams.
  • Manage post-approval regulatory activities, including variations, supplements, and annual reports.
  • Conduct regulatory intelligence activities to stay informed of evolving requirements.
  • Contribute to the development of regulatory policies and procedures.
  • Mentor and guide junior regulatory affairs professionals.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
  • Extensive experience in pharmaceutical regulatory affairs.
  • Proven track record of successful regulatory submissions and approvals.
  • In-depth knowledge of global regulatory requirements and guidelines.
  • Experience with Common Technical Document (CTD) format.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Ability to work independently, manage priorities, and thrive in a remote setting.
  • Strong analytical and problem-solving skills.
  • Experience with specific therapeutic areas is a plus.
This advertiser has chosen not to accept applicants from your region.

Regulatory Compliance Officer

Bristol, South West Pontoon

Posted 4 days ago

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Job Description

contract

Job Title: Regulatory Compliance Officer
Location: Hybrid - Castle Donington or Bristol (initially more office-based for training, then minimum 2 days/week - Monday is team anchor day)
Contract Length: 6 months initially (potential for extension)
Rate: 25.50 per hour PAYE

About the Role

A newly formed regulatory compliance team is seeking a proactive and detail-oriented Regulatory Compliance Officer to support the handling of escalated customer complaints. This role involves independently reviewing complex cases, preparing formal responses, and compiling case files for external regulatory bodies.

The successful candidate will play a key role in ensuring the organisation meets its regulatory obligations while maintaining high standards of customer service and accountability.

Key Responsibilities

  • Manage complaints escalated to Stage 3 and Stage 4 of the formal complaints procedure.
  • Gather and assess information from internal systems and colleagues to build a comprehensive timeline of events.
  • Independently determine whether the organisation's position should be upheld or overruled and propose remedies where appropriate.
  • Draft and issue Stage 3 letters to customers, either offering a resolution or placing the case in "deadlock".
  • Prepare structured case files for submission to external regulators, including timelines, evidence, and the organisation's final position.
  • Maintain accurate records of escalated complaints, including outcomes and regulatory findings.
  • Support the wider Regulatory Compliance Team with related duties as required.

Skills & Experience

  • Strong written communication skills, with the ability to produce clear, concise, and professional correspondence.
  • Proven ability to interrogate qualitative information, assess complex scenarios, and make sound decisions.
  • Experience in complaint handling, regulatory compliance, or customer resolution roles.
  • Highly organised, with excellent attention to detail and the ability to manage multiple cases simultaneously.
  • Comfortable working independently and taking ownership of outcomes.
  • Background in a regulated industry (e.g., utilities, telecoms, financial services).
  • Familiarity with regulatory frameworks such as the Electricity Act, licence conditions, or regulator guidance.

Please note: Due to the high volume of applications, only shortlisted candidates will be contacted. If you do not hear from us within 48 hours, your application has not been successful on this occasion. However, we may retain your details for future suitable opportunities.

Pontoon is an employment consultancy. We put expertise, energy, and enthusiasm into improving everyone's chance of being part of the workplace. We respect and appreciate people of all ethnicities, generations, religious beliefs, sexual orientations, gender identities, and more. We do this by showcasing their talents, skills, and unique experience in an inclusive environment that helps them thrive. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.

This advertiser has chosen not to accept applicants from your region.

Regulatory Compliance Officer

Castle Donington, East Midlands Pontoon

Posted 4 days ago

Job Viewed

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Job Description

contract

Job Title: Regulatory Compliance Officer
Location: Hybrid - Castle Donington or Bristol (initially more office-based for training, then minimum 2 days/week - Monday is team anchor day)
Contract Length: 6 months initially (potential for extension)
Rate: 25.50 per hour PAYE

About the Role

A newly formed regulatory compliance team is seeking a proactive and detail-oriented Regulatory Compliance Officer to support the handling of escalated customer complaints. This role involves independently reviewing complex cases, preparing formal responses, and compiling case files for external regulatory bodies.

The successful candidate will play a key role in ensuring the organisation meets its regulatory obligations while maintaining high standards of customer service and accountability.

Key Responsibilities

  • Manage complaints escalated to Stage 3 and Stage 4 of the formal complaints procedure.
  • Gather and assess information from internal systems and colleagues to build a comprehensive timeline of events.
  • Independently determine whether the organisation's position should be upheld or overruled and propose remedies where appropriate.
  • Draft and issue Stage 3 letters to customers, either offering a resolution or placing the case in "deadlock".
  • Prepare structured case files for submission to external regulators, including timelines, evidence, and the organisation's final position.
  • Maintain accurate records of escalated complaints, including outcomes and regulatory findings.
  • Support the wider Regulatory Compliance Team with related duties as required.

Skills & Experience

  • Strong written communication skills, with the ability to produce clear, concise, and professional correspondence.
  • Proven ability to interrogate qualitative information, assess complex scenarios, and make sound decisions.
  • Experience in complaint handling, regulatory compliance, or customer resolution roles.
  • Highly organised, with excellent attention to detail and the ability to manage multiple cases simultaneously.
  • Comfortable working independently and taking ownership of outcomes.
  • Background in a regulated industry (e.g., utilities, telecoms, financial services).
  • Familiarity with regulatory frameworks such as the Electricity Act, licence conditions, or regulator guidance.

Please note: Due to the high volume of applications, only shortlisted candidates will be contacted. If you do not hear from us within 48 hours, your application has not been successful on this occasion. However, we may retain your details for future suitable opportunities.

Pontoon is an employment consultancy. We put expertise, energy, and enthusiasm into improving everyone's chance of being part of the workplace. We respect and appreciate people of all ethnicities, generations, religious beliefs, sexual orientations, gender identities, and more. We do this by showcasing their talents, skills, and unique experience in an inclusive environment that helps them thrive. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.

This advertiser has chosen not to accept applicants from your region.
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Regulatory Compliance Officer

Bishopsgate, London Prime Personnel UK

Posted 5 days ago

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Job Description

full time

A prestigious international Bank is seeking a dynamic individual to join its Compliance area. Your role will involve supporting the Head of Compliance to ensure full adherence to UK regulations and the expectations of local regulators.

Responsibilities will include:

  • Providing guidance and training to staff regarding compliance and UK Data Protection Regulations, PRA/FCA Outsourcing, third-party risk management and Senior Managers & Certification Regime
  • li>Conducting compliance monitoring programmes and reporting findings
  • Reviewing/maintaining the London office policy & procedure and framework on compliance with UK GDPR/data protection
  • Reviewing the London office framework on compliance with PRA/FCA and Senior Managers & Certification Regime
  • Assisting business areas with implementation plans for any policy/procedural changes   
  • < i>Assisting with monitoring activities regarding Conduct Risk, Operational Resilience etc
  • Preparing various compliance reports

Your experience must include:  

    li>Strong proven experience in regulatory compliance gained within banking – including compliance regarding Data Protection, PRA/FCA Outsourcing and third-party risk management < i>Excellent presentation skills – both oral and written < i>Good understanding of PRA/FCA,  Senior Managers & Certification Regime, regulatory reporting and risk management framework    Strong IT skills   li>A proactive “hands-on” approach, showing initiative to assist with projects

Please note this role will be working 5 days a week in the office for the first month, transitioning to hybrid thereafter (3 days in the office and 2 days remote).

This advertiser has chosen not to accept applicants from your region.

Manager - Regulatory Compliance

Barbara Houghton Associates

Posted 6 days ago

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Job Description

full time

Sponsorship will not be available for this position, therefore 3+ years on visa eligibility to work in UK is essential.

Our client, a highly respected Bank, is seeking a Manager – Regulatory Compliance to join their team on a permanent basis.

This position forms an integral part of 2nd Line of Defence and the successful candidate will also be performing regular and comprehensive compliance risk assessments according to the approved compliance plan, report on a regular basis on compliance identified breaches and corrective actions taken, as applicable.

Under direction, draft the Scope of Regulatory Compliance oversight as part of the annual plan and adhere to the plan by performing reviews and following up on outstanding actions.

Responsibilities (but not limited to):
•    Determine the processes and sub-processes, including input, processing and output.
•    Perform an end-to-end review of each process and determine relevant risks and controls.
•    Undertake root-cause analysis to address and mitigate the identified risks and recommend adequate remedial action.
•    Facilitate controls gap analysis, remediation planning and testing for all business units.
•    Ensure that the controls are efficient and effective, thus maintaining risks at an acceptable level.
•    Ensure that the processes are in compliance with regulatory requirements and best practices, at governance, oversight and operational levels.
•    Provide counsel and advice to the various functions in view of enhancing the control structure.
•    Review the branch’s policies, procedures and systems, before implementation, in order to assess the inherent risks, determine sufficiency of controls, and convey approval.
•    Undertake a continuous Control Self-Assessment exercise.
•    Maintain an updated Compliance Risk Register detailing the determined Compliance risks.

Qualifications and Skills:
•    University graduate preferably with a Major in Marketing, Banking, Finance, Accounting, Economics, Business Administration or Information Technology (related field of study).
•    At least 6 years of relevant experience, preferably in banking within a highly rated international bank. Also experience with regulated mortgages, savings accounts and fixed term deposits.
•    Excellent oral and written communication skills (including report writing) in English.
•    Awareness of customer relationship practices and regulations.

For more information on this role please contact Sonia Smith by sending your CV quoting ref 16905SS.


 

This advertiser has chosen not to accept applicants from your region.

Regulatory Compliance Officer

Bristol, South West Pontoon

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

contract

Job Title: Regulatory Compliance Officer
Location: Hybrid - Castle Donington or Bristol (initially more office-based for training, then minimum 2 days/week - Monday is team anchor day)
Contract Length: 6 months initially (potential for extension)
Rate: 25.50 per hour PAYE

About the Role

A newly formed regulatory compliance team is seeking a proactive and detail-oriented Regulatory Compliance Officer to support the handling of escalated customer complaints. This role involves independently reviewing complex cases, preparing formal responses, and compiling case files for external regulatory bodies.

The successful candidate will play a key role in ensuring the organisation meets its regulatory obligations while maintaining high standards of customer service and accountability.

Key Responsibilities

  • Manage complaints escalated to Stage 3 and Stage 4 of the formal complaints procedure.
  • Gather and assess information from internal systems and colleagues to build a comprehensive timeline of events.
  • Independently determine whether the organisation's position should be upheld or overruled and propose remedies where appropriate.
  • Draft and issue Stage 3 letters to customers, either offering a resolution or placing the case in "deadlock".
  • Prepare structured case files for submission to external regulators, including timelines, evidence, and the organisation's final position.
  • Maintain accurate records of escalated complaints, including outcomes and regulatory findings.
  • Support the wider Regulatory Compliance Team with related duties as required.

Skills & Experience

  • Strong written communication skills, with the ability to produce clear, concise, and professional correspondence.
  • Proven ability to interrogate qualitative information, assess complex scenarios, and make sound decisions.
  • Experience in complaint handling, regulatory compliance, or customer resolution roles.
  • Highly organised, with excellent attention to detail and the ability to manage multiple cases simultaneously.
  • Comfortable working independently and taking ownership of outcomes.
  • Background in a regulated industry (e.g., utilities, telecoms, financial services).
  • Familiarity with regulatory frameworks such as the Electricity Act, licence conditions, or regulator guidance.

Please note: Due to the high volume of applications, only shortlisted candidates will be contacted. If you do not hear from us within 48 hours, your application has not been successful on this occasion. However, we may retain your details for future suitable opportunities.

Pontoon is an employment consultancy. We put expertise, energy, and enthusiasm into improving everyone's chance of being part of the workplace. We respect and appreciate people of all ethnicities, generations, religious beliefs, sexual orientations, gender identities, and more. We do this by showcasing their talents, skills, and unique experience in an inclusive environment that helps them thrive. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.

This advertiser has chosen not to accept applicants from your region.
 

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