Regulatory Affairs Manager

London, London Walker Cole International

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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 //

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Regulatory Affairs Manager

London, London Walker Cole International

Posted today

Job Viewed

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Job Description

Job Description

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 //

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

Regulatory Affairs Manager - CMC

London, London Hobson Prior

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Job Description

Hobson Prior is seeking a Regulatory Affairs Manager - CMC to join a dynamic team in the biotech industry. In this role, you will focus on regulatory strategies and submissions related to Chemistry, Manufacturing, and Controls (CMC). This is an exciting opportunity to contribute to pre-clinical and early-phase projects in a rapidly evolving therapeutic area.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Lead the preparation of regulatory documents, including clinical trial applications (CTA), investigational new drug (IND) submissions, and genetically modified organism (GMO) applications.
  • Collaborate with various teams to ensure manufacturing and analytical processes meet regulatory standards.
  • Provide strategic input on regulatory pathways for complex biologics or biotech products.

Key Skills and Requirements:

  • Strong understanding of regulatory processes, particularly in the EU and US.
  • Experience with biologics, with a preference for candidates familiar with cell and gene therapy.
  • Ability to work effectively across teams and adapt to a fast-paced environment.

For more information, please contact Syem Mannan .

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -

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

Regulatory Affairs Manager - CMC

London, London Hobson Prior

Posted today

Job Viewed

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Job Description

Job Description

Hobson Prior is seeking a Regulatory Affairs Manager - CMC to join a dynamic team in the biotech industry. In this role, you will focus on regulatory strategies and submissions related to Chemistry, Manufacturing, and Controls (CMC). This is an exciting opportunity to contribute to pre-clinical and early-phase projects in a rapidly evolving therapeutic area.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Lead the preparation of regulatory documents, including clinical trial applications (CTA), investigational new drug (IND) submissions, and genetically modified organism (GMO) applications.
  • Collaborate with various teams to ensure manufacturing and analytical processes meet regulatory standards.
  • Provide strategic input on regulatory pathways for complex biologics or biotech products.

Key Skills and Requirements:

  • Strong understanding of regulatory processes, particularly in the EU and US.
  • Experience with biologics, with a preference for candidates familiar with cell and gene therapy.
  • Ability to work effectively across teams and adapt to a fast-paced environment.

For more information, please contact Syem Mannan .

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - -policy.

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

Remote Pharmaceutical Regulatory Affairs Manager

SW1A 0AA London, London £70000 Annually WhatJobs

Posted 21 days ago

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full-time
Our client, a globally recognised pharmaceutical organisation dedicated to enhancing global health outcomes, is seeking a strategic and experienced Remote Pharmaceutical Regulatory Affairs Manager. This is a critical, fully remote position where you will drive the regulatory strategy and execution for our innovative product portfolio. You will be responsible for ensuring compliance with all relevant national and international pharmaceutical regulations, including those set by the MHRA, EMA, and FDA. The ideal candidate will possess extensive experience in pharmaceutical regulatory affairs, with a deep understanding of drug development, manufacturing, and lifecycle management. Your responsibilities will include preparing and submitting regulatory dossiers (e.g., CTAs, MAAs, NDAs), responding to health authority queries, and managing post-approval regulatory activities. You will stay abreast of evolving regulatory landscapes, providing expert guidance to internal teams on regulatory requirements and strategies. Excellent analytical, communication, and project management skills are paramount. You will collaborate closely with R&D, clinical operations, quality assurance, and commercial teams to ensure seamless integration of regulatory considerations into project timelines and strategies. This role demands a proactive approach to regulatory compliance and a strong ability to navigate complex regulatory challenges. Experience in strategic regulatory planning, regulatory intelligence, and health authority interactions is essential. You will be a key advisor on regulatory policy and compliance, ensuring our products reach patients safely and effectively. This remote role offers the flexibility to work from your home office, contributing significantly to our company's mission, while being an integral part of our client's operations, which have a significant presence in **London, England, UK**, and globally.
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Regulatory Affairs Manager (12 Month FTC)

London, London Advocate Group

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Job Description

We are seeking an experienced Regulatory Affairs Manager to join on a 12-month fixed-term contract , supporting compliance and nutrition across multiple European markets. This is a senior role with broad cross-functional exposure, ideal for someone with strong regulatory expertise who thrives in a fast-paced international environment.


Key Responsibilities

  • Act as a subject matter expert on European food regulations, labelling, and claims.
  • Provide expert guidance on regulatory matters for existing, new, and reformulated products.
  • Lead the regulatory review and approval of consumer labels in English and French, with potential oversight of additional European markets.
  • Manage and resolve complex regulatory incidents , engaging with internal teams and external authorities.
  • Monitor and interpret emerging legislation , shaping compliance strategies and contributing to industry discussions.
  • Support cross-functional projects, including product development, reformulations, and marketing communications.
  • Drive improvements in regulatory processes and systems, including the rollout of new labelling software.
  • Manage and develop contractors, ensuring delivery of compliance-related activities.


About You

  • Degree in Life Sciences required; Master’s preferred.
  • 8–10+ years’ experience in regulatory affairs/nutrition with a strong focus on European markets.
  • 5+ years’ experience leading teams preferred.
  • Deep knowledge of European food regulations and labelling requirements.
  • Fluent in English and French (additional European languages an advantage).
  • Excellent communication and influencing skills, with proven ability to manage senior stakeholders.
  • Skilled in Microsoft Office, Adobe, SAP-PLM, and product lifecycle management systems .


What’s on Offer

  • A 12-month fixed-term contract with significant responsibility and visibility.
  • The opportunity to work across multiple markets and regulatory environments.
  • A chance to shape compliance processes and contribute to industry discussions at European level.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager (12 Month FTC)

London, London Advocate Group

Posted today

Job Viewed

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Job Description

Job Description

We are seeking an experienced Regulatory Affairs Manager to join on a 12-month fixed-term contract , supporting compliance and nutrition across multiple European markets. This is a senior role with broad cross-functional exposure, ideal for someone with strong regulatory expertise who thrives in a fast-paced international environment.


Key Responsibilities

  • Act as a subject matter expert on European food regulations, labelling, and claims.
  • Provide expert guidance on regulatory matters for existing, new, and reformulated products.
  • Lead the regulatory review and approval of consumer labels in English and French, with potential oversight of additional European markets.
  • Manage and resolve complex regulatory incidents , engaging with internal teams and external authorities.
  • Monitor and interpret emerging legislation , shaping compliance strategies and contributing to industry discussions.
  • Support cross-functional projects, including product development, reformulations, and marketing communications.
  • Drive improvements in regulatory processes and systems, including the rollout of new labelling software.
  • Manage and develop contractors, ensuring delivery of compliance-related activities.


About You

  • Degree in Life Sciences required; Master’s preferred.
  • 8–10+ years’ experience in regulatory affairs/nutrition with a strong focus on European markets.
  • 5+ years’ experience leading teams preferred.
  • Deep knowledge of European food regulations and labelling requirements.
  • Fluent in English and French (additional European languages an advantage).
  • Excellent communication and influencing skills, with proven ability to manage senior stakeholders.
  • Skilled in Microsoft Office, Adobe, SAP-PLM, and product lifecycle management systems .


What’s on Offer

  • A 12-month fixed-term contract with significant responsibility and visibility.
  • The opportunity to work across multiple markets and regulatory environments.
  • A chance to shape compliance processes and contribute to industry discussions at European level.

This advertiser has chosen not to accept applicants from your region.
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EU Regulatory Affairs Senior Manager - Oncology

Uxbridge, London Amgen

Posted 20 days ago

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Job Description

**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
**SENIOR REGULATORY AFFAIRS MANAGER**
**LIVE**
**What you will do**
In this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
Representing the EU region, you will be responsible for advising the GRT on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
+ Develop and execute regional regulatory product strategies, including precedence, risk management and contingency planning
+ Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
+ Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
+ Lead development of regional regulatory documents and meetings in accordance with GRT strategy
+ Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
+ Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
+ Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
**Be part of our team**
You would be joining the European Regulatory team, part of the Global Regulatory Affairs function in Europe. You would be responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.
This team is leading the regulatory activities for established products and also development assets.
**WIN**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
+ Degree educated in a scientific discipline
+ Extensive experience in regional regulatory environment
+ Proven track record of developing and executing regional regulatory strategy
+ In-depth understanding of the drug life cycle and development process from a regulatory perspective
+ In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
+ Ability to lead teams and work collaboratively in a dynamic environment
+ Proactive approach to problem solving
+ Ability to understand and communicate scientific/clinical information
+ Ability to anticipate regulatory agency expectations
+ Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
**THRIVE**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Growth opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
The position can also be located in our Lisbon office.
**APPLY NOW**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Regulatory Compliance Manager - LONDON - London

London, London Capgemini

Posted 2 days ago

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Regulatory Compliance Manager - LONDON - London Reference Code: -en_USContract Type: PermanentProfessional Communities: Data & AI

Shape the Future with Capgemini

At Capgemini, we empower you to shape your career your way. Join a global community where collaboration, innovation, and purpose come together to reimagine what’s possible. Be part of a team that helps the world’s leading organizations unlock the power of technology to build a more sustainable and inclusive future.

Job Title: Manager – Financial Crime Compliance (FCC) Advisory

We have a very exciting opportunity for a Manager  to join our growing Capgemini Financial Crime Compliance (FCC) Advisory  business. As a Manager, you will play a pivotal role in helping leading financial services organisations enhance their FCC programmes. You’ll work across multiple complex engagements, delivering superior results and contributing to business development efforts

Key Responsibilities:

  • Lead and participate in client engagements focused on managing financial crime-related issues.
  • Prepare written analyses, status reports, and presentations for key stakeholders.
  • Build and maintain productive relationships with clients and internal teams.
  • Identify and pursue business development opportunities through client work, proposals, and thought leadership.
  • Manage project delivery, ensuring timelines, budgets, and quality standards are met.
  • Supervise day-to-day project activities, including client interactions and team coordination.
  • Conduct client interviews and support the development of effective lines of questioning.
  • Maintain detailed documentation of methodologies, assumptions, and sources used in analysis.

Knowledge & Skills:

  • Ability to evaluate internal control structures and identify risks.
  • Experience writing or uplifting financial crime policies, procedures, and processes across AML, ABC, Sanctions, and Fraud.
  • Expertise in assessing and designing financial crime Target Operating Models (TOMs) across CLM, Sanctions, TM, and Fraud.
  • Strong understanding of financial services products across banks, payment firms, insurers, and fintechs.
  • Knowledge of UK and European financial crime regulations.
  • Familiarity with internal control frameworks, the three lines of defence model, and financial crime operations (KYC/CDD/EDD, Screening, TM, Fraud).
  • Understanding of TM and screening systems, including matching logic and alert dispositioning.
  • Strong analytical, research, and problem-solving skills.
  • Ability to manage multiple evolving tasks and meet strict deadlines.
  • Proficiency in using technology creatively to solve complex problems.
  • High-quality documentation and reporting skills.

Professional Experience Required:

  • Bachelor’s degree in Law, Accounting, or related field; professional certifications preferred.
  • 5–8 years  of experience in financial services compliance or consulting, ideally within AML or sanctions roles.
  • Experience in heavily regulated environments and FCC teams.
  • Willingness to travel domestically and internationally (20–30%) based on client needs.

About Capgemini

Capgemini is a global leader in business and technology transformation. With 340,000 team members in over 50 countries, we help organizations accelerate their digital and sustainable transitions. Backed by over 55 years of experience, we deliver end-to-end solutions powered by AI, cloud, and data, and supported by deep industry expertise. In 2023, Capgemini reported global revenues of €22.5 billion.Get the future you want

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Regulatory Compliance Manager (FinTech:PI/EMI)

London, London YouLend

Posted 18 days ago

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Permanent

About Us

YouLend is a rapidly growing FinTech that is the preferred embedded financing platform for many of the world’s leading e-commerce platforms, tech companies, and Payment Service Providers. Our software platform enables our partners to extend their value proposition by offering flexible financing products in their own branding, to their merchant base, without capital at risk.  

We are owned by the leading Private Equity company, EQT, and have grown +100% year-on-year since 2020. We are headquartered in London, UK, but are also present in several European countries as well as the United States where we service our partners, including eBay, Amazon, Just Eat, Shopify, and Stripe.    

The Role

The Regulatory Compliance Manager will be a key figure in ensuring YouLend maintains a robust regulatory compliance framework. Reporting directly to the Head of Regulatory Compliance this role will focus on enhancing compliance processes, monitoring regulatory risks, and ensuring adherence to FCA, EU, and global standards as we pursue additional regulatory authorisations. 

This role offers an exciting opportunity for an experienced compliance professional to play a pivotal role in helping to shape our regulatory compliance framework and support YouLend with future expansion plans.  

Requirements

Responsibilities: 

  • Regulatory Compliance Framework – Contribute to the maturity of the regulatory compliance strategy and framework, ensuring there is a consistent and scalable approach to ‘compliance’ across training, policies, KRIs, testing, reporting. 
  • Compliance Monitoring -  Support with the enhancement of the design and implementation of YouLend's Compliance Monitoring and Testing Programme including tracking and monitoring progress against the annual monitoring program and adapting it to the changing regulatory and business environment. 
  • Governance and Management Reporting - Raising the standards of management reporting and governance, assisting the Head of Regulatory Compliance with preparing updates to YouLend’s Senior Management Team where necessary and embedding a governance framework that facilitates this.   
  • Horizon scanning - Through the identification, assessment, and ongoing monitoring of current and future regulatory risks, including gap analysis of new regulatory initiatives and guidance from the Youlend’s regulators 
  • Advisory – Act as a trusted advisor to the business, providing guidance on regulatory topics and helping the business navigate complex compliance landscapes in the UK, EU, US and other jurisdictions. 
  • Regulatory Engagement - Support the Head of Regulatory Compliance with managing regulatory engagement, tracking and handling queries, audits, and ongoing communications with YouLend’s Regulators. 
  • Regulatory Reporting - Lead regulatory reporting processes to ensure timely and accurate submissions to the FCA and other relevant authorities. 
  • Enterprise Risk Management -  Support with the uplift of YouLend’s Enterprise Risk Framework, working with risk owners across the business to develop and mature the identification, assessment and management of  YouLend’s enterprise risks. 

The ideal candidate will have the following skillset:  

  • 3- 5 years’ experience in a regulatory compliance role, ideally within a payment institution, electronic money institution or a similar regulated entity. 
  • Strong analytical skills with the ability to identify and solve complex business problems 
  • Demonstrable experience of supporting the implementation of compliance frameworks, particularly for FCA-regulated entities. 
  • Experience leading regulatory reporting processes. 
  • Familiarity with EU regulatory regimes and experience supporting applications for new regulatory authorizations is a strong plus. 
  • Experience working in B2B financing or corporate lending is desirable. 
  • Experience applying statistical techniques and analytical methods to extract insights from data.  

Desirable skills:

  • Strong knowledge of FCA regulatory requirements, including the FCA Handbook and Payment Services Regulations (PSRs).  
  • Proven ability to assess and manage regulatory risks, with experience in conducting thematic reviews and compliance monitoring. 
  • Expertise in key compliance themes such as governance, complaints handling, safeguarding, product governance and outsourcing, and in depth understanding of risk mitigation frameworks. 
  • Exceptional analytical skills, including conducting gap analyses to address new regulatory initiatives and guidance. 
  • Strong written and verbal communication skills, with experience preparing high-quality reviews, assessments, and reports for senior stakeholders and regulators. 

Benefits

Why join YouLend?   

  • Award-Winning Workplace: YouLend has been recognised as one of the “Best Places to Work in 2024 and 2025” by the Sunday Times for being a supportive, diverse, and rewarding workplace. 
  • Award-Winning Fintech: YouLend has been recognised as a “Top 250 Fintech Worldwide” company by CNBC. 

It’s just getting fun: 

  • We have developed powerful solutions, won some significant partnerships, and are growing at a rapid pace.  
  • But the global opportunity is still massive, and YouLend is a raw organisation where we are only just getting started.  

Lots of upsides: 

  • High-growth (>100% growth during 2022 and 2023), so clear outlook to compensation (bonus or share option appreciation) and career growth (through growth with business).  
  • Well-capitalised with supportive private equity backing.  
  • Part of Banking Circle Group with a fully licensed Luxembourg bank, which can provide a balance sheet and support European expansion in otherwise complex regulated markets.  

Motivating work environment:  

  • A high-quality team that pushes each other to succeed through direct feedback and aligned incentives.  
  • Strong and transparent team culture, we have each other’s backs.  
  • Independent work environment where results matter.   
  • Data-driven culture and emphasis on speed (anti-red tape).  

We offer a comprehensive benefits package that includes:   

  • Stock Options 
  • Private Medical insurance via Vitality and Dental Insurance with BUPA  
  • EAP with Health Assured 
  • Enhanced Maternity and Paternity Leave 
  • Modern and sophisticated office space in Central London 
  • Free Gym in office building in Holborn 
  • Subsidised Lunch via Feedr 
  • Deliveroo Allowance if working late in office 
  • Monthly in office Masseuse 
  • Team and Company Socials 
  • Football Power League / Paddle and Yoga Club  

At YouLend, we champion diversity and embrace equal opportunity employment practices. Our hiring, transfer, and promotion decisions are exclusively based on qualifications, merit, and business requirements, free from any discrimination based on race, gender, age, disability, religion, nationality, or any other protected basis under applicable law. 

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