Regulatory affairs lead Work, Jobs in Eng (with Salaries)

EU Regulatory Affairs Manager (Biosimilars)
Amgen —London
- £48,957 - £66,237 a year
- Remote
- Continuous improvement
- Conflict management
- Communication skills
- Work from home
4d
Regulatory, Data Protection and Ethics Lead
Foundation Partners —London
- Hybrid work
- AI
- Negotiation
Quick apply
EU Regulatory Affairs Manager
Amgen —London
- £48,957 - £66,237 a year
- Remote
- Research
- Conflict management
- AI
- Work from home
Specialist/Snr Specialist Study Start Up and Regulatory Affairs
Ergomed —Guildford
- Full-time
- Remote
- Nursing
- No degree
- Quality control
Quick apply
3d
GB Sr. Manager, Regulatory Affairs - Europe
The Bountiful Company —London
- Writing skills
- Bachelor's degree
- Training & development
Quick apply
Senior Regulatory Affairs Specialist
Smith & Nephew —Kingston upon Hull
- Full-time
- Hybrid work
- Project management
- Continuous improvement
- Annual leave
- Employee discount
Manager - Regulatory Affairs Lifecycle Management - Medicines
Perrigo —London
- Hybrid work
- Marketing
- English
- Continuous improvement
10h
Sr Director, Drug Development Lead
IQVIA —Reading
- Full-time
- Remote
- Management
- Doctoral degree
- Master's degree
- Work from home
12d
Corporate Public Affairs Lead
Roche —Welwyn
- Communication skills
Regulatory Affairs Specialist
Cambridge Consultants —Cambridge
- Continuous improvement
- Leadership
Regulatory Affairs Professional - Lifecycle Management - Non-Medicinal
Perrigo —London
- Hybrid work
- Continuous improvement
- In-person
4h
Quality Assurance & Regulatory Affairs Executive - Maternity Cover
TensCare Ltd —Epsom
- £35,000 - £42,500 a year
- Temporary
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
- Profit sharing
- Work from home
Quick apply
Regulatory Affairs Manager
Boots —Nottingham
- Full-time
- Organisational skills
- Leadership
- Communication skills
- Employee assistance programme
- Employee discount
Senior Professional - Regulatory Affairs Lifecycle Management - Biocides
Perrigo —London
- Hybrid work
- Continuous improvement
- Mentoring
- In-person
11d
Patient-Centered Outcomes Research (PCOR) Lead (UK)
UCB —Slough
- Doctoral degree
- Master's degree
- Leadership
Senior Professional Regulatory Affairs - Lifecycle Management - Non-Medicinal
Perrigo —London
- Hybrid work
- English
- Continuous improvement
- Mentoring
4h
Regulatory Innovation & Nutrition Manager
Campden BRI —Chipping Campden
- Remote
- Business development
- Project management
- Continuous improvement
- Employee discount
Global Regulatory Affairs Manager
GlaxoSmithKline —London
- £98,250 - £163,750 a year
- Full-time
- Doctoral degree
- Writing skills
- Bachelor's degree
9d
Senior Regulatory Affairs Consultant
Taylored Consultancy —Birmingham
- From £45,000 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Mentoring
- AI
Quick apply
4d
Medical Affairs Coordinator
Servier —Slough
- Microsoft Office
- Databases
- Administrative experience

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EU Regulatory Affairs Manager (Biosimilars)

Amgen -
London

Apply Now

Job details

£48,957 - £66,237 a year
4 days ago

Benefits

Work from home

Qualifications

Labelling
Compliance management
Continuous improvement
Conflict management
Multidisciplinary collaboration
Cross-functional collaboration
Communication skills
Negotiation
Cross-functional communication

Full job description

United Kingdom - Uxbridge

JOB ID: R-252420 LOCATION: United Kingdom - Uxbridge ; United Kingdom - London; United Kingdom - Manchester; United Kingdom - Remote; United Kingdom - Edinburgh; United Kingdom - Cambridge; Portugal - Lisbon WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Aug. 25, 2026 CATEGORY: Regulatory

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.

EU REGULATORY AFFAIRS MANAGER - BIOSIMILARS

LIVE

What you will do

In this vital role you will contribute to the development and execution of European regulatory strategies for Amgen’s biosimilar portfolio, supporting products from development and registration through launch and lifecycle management.

Plan and manage EU/EEA regulatory submissions, including MAAs, responses to Health Authorities, CTAs/CTIS activities and post-approval lifecycle submissions.
Partner with global and regional cross-functional teams, including CMC, Clinical, Safety, Quality, Legal and Commercial.
Lead and support Health Authority interactions, including preparation of briefing materials, regulatory responses and follow-up actions.
Support product information and labelling activities, including SmPC, Package Leaflet, artwork and regional label negotiations.
Ensure regulatory compliance and maintenance of filings throughout development and the product lifecycle.
Monitor evolving EU biosimilar legislation, guidance, regulatory policy and competitor intelligence, assessing potential impact on regulatory strategies.
Contribute to regulatory processes, SOPs, templates and continuous improvement initiatives.

Be part of our team

We are currently looking for a Regulatory Affairs Manager based in either Portugal or the United Kingdom.

You would be joining the European Regulatory Team, part of the Global Regulatory Affairs function in Europe. You would be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from clinical trials to marketing authorisation, and throughout the products lifecycle.

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.
Knowledge of drug development for Biosimilars within a regional regulatory environment including direct experience with EU biosimilar submissions and post-approval maintenance.
Proven experience working with policies, procedures and SOP’s.
Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
Experience with EU Centralised Procedure and understanding of EU regulatory incentives.
Strong communication skills - both oral and written.
Ability to anticipate and prevent potential issues.
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
Experience in a global or matrixed organization with collaboration across multiple regions.

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: Flexibility to work from home with few days per month working from our Cambridge, Uxbridge or Lisbon office.

The expected gross pay range for this role in Portugal is EUR 48,957.00 to EUR 66,237.00. Actual pay will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

For candidates based in the UK, compensation will be aligned with the local market and role requirements, with further details discussed during the recruitment process.

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, 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.

Apply Now

Refine Your Search

regulatory affairs lead jobs in eng

EU Regulatory Affairs Manager (Biosimilars)

Regulatory, Data Protection and Ethics Lead

EU Regulatory Affairs Manager

Specialist/Snr Specialist Study Start Up and Regulatory Affairs

GB Sr. Manager, Regulatory Affairs - Europe

Senior Regulatory Affairs Specialist

Manager - Regulatory Affairs Lifecycle Management - Medicines

Sr Director, Drug Development Lead

Corporate Public Affairs Lead

Regulatory Affairs Specialist

Regulatory Affairs Professional - Lifecycle Management - Non-Medicinal

Quality Assurance & Regulatory Affairs Executive - Maternity Cover

Regulatory Affairs Manager

Senior Professional - Regulatory Affairs Lifecycle Management - Biocides

Patient-Centered Outcomes Research (PCOR) Lead (UK)

Senior Professional Regulatory Affairs - Lifecycle Management - Non-Medicinal

Regulatory Innovation & Nutrition Manager

Global Regulatory Affairs Manager

Senior Regulatory Affairs Consultant

Medical Affairs Coordinator

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