25 Regulatory Affairs Specialists jobs in London

Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.

A Regulatory Manager will bring:

• Regulatory CMC experience at early-stage development in ATMP and/or biological products
• A drive and willingness to learn and grow within this space.
• Ability to work well within a team, cross functionally and independently

As a Regulatory Manager you will:

• Work within an expert team on Regulatory CMC
• Support in CMC gap analysis, write guidance document and IMAPs
• IMPD, IND submissions and pre-clinical activities.

Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //

Overall Job Purpose:

The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.

Responsibilities:

• Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports.
• Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
• Is responsible for text verification of the product information documents.
• Is responsible for proof reading of art work of packaging materials.
• Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
• Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
• Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
• Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
• Maintains RA archives (electronically).
• Keeps the Regulatory Information correct and accessible for other stakeholders.
• Being able to work with the required IT standards, like eCTD, XEVMPD
• Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR
• Determines and writes standard operating procedures.

Qualifications:

• Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
• 2-5 years of experience in pharma
• Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
• Some understanding of the drug development process
• Able to comply with company standard operating procedures
• Good verbal and written communication skills in English
• Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
• Excellent attention to detail
• Good time management skills
• Good organization and project management skills
• Good interpersonal and team working skills
• Presentation skills and experience of delivering training

Join a leading innovator in the chemical sector, driving compliance and sustainability across global markets. We’re seeking a detail-oriented Regulatory Affairs Specialist with a strong foundation in chemical regulations to ensure our products meet all legal and safety standards.

The Role

As a Regulatory Affairs Specialist , you will play a pivotal role in managing product registrations, preparing regulatory documentation, and maintaining compliance with national and international chemical legislation (REACH, CLP, SDS, etc.). You’ll collaborate with R&D, Quality, and Commercial teams to support new product introductions and ensure continuous regulatory alignment.

Key Responsibilities

• Prepare, review, and submit product registration dossiers and notifications.
• Maintain up-to-date knowledge of chemical regulations and compliance requirements.
• Support Safety Data Sheet (SDS) authoring and classification activities.
• Liaise with regulatory authorities and third-party consultants.
• Contribute to internal audits and compliance projects.
• Provide regulatory guidance for product development and market access.

The requirements

• Bachelor’s degree (or higher) in Chemistry, Toxicology, Environmental Science, or a related field.
• Minimum 2 years’ experience in regulatory affairs within the chemical, pharmaceutical, nutraceutical and/or food industries .
• Working knowledge of REACH, CLP, and GHS regulations.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple projects and deadlines effectively.

Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.

A Regulatory Manager will bring:

• Regulatory CMC experience at early-stage development in ATMP and/or biological products
• A drive and willingness to learn and grow within this space.
• Ability to work well within a team, cross functionally and independently

As a Regulatory Manager you will:

• Work within an expert team on Regulatory CMC
• Support in CMC gap analysis, write guidance document and IMAPs
• IMPD, IND submissions and pre-clinical activities.

Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //

Overall Job Purpose:

The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.

Responsibilities:

• Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports.
• Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
• Is responsible for text verification of the product information documents.
• Is responsible for proof reading of art work of packaging materials.
• Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
• Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
• Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
• Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
• Maintains RA archives (electronically).
• Keeps the Regulatory Information correct and accessible for other stakeholders.
• Being able to work with the required IT standards, like eCTD, XEVMPD
• Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR
• Determines and writes standard operating procedures.

Qualifications:

• Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
• 2-5 years of experience in pharma
• Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
• Some understanding of the drug development process
• Able to comply with company standard operating procedures
• Good verbal and written communication skills in English
• Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
• Excellent attention to detail
• Good time management skills
• Good organization and project management skills
• Good interpersonal and team working skills
• Presentation skills and experience of delivering training