Regulatory affairs manager Work, Jobs in Hatfield, Hrt (with Salaries)

EU Regulatory Affairs Manager
Amgen —London
- £48,957 - £66,237 a year
- Remote
- Work from home
GB Sr. Manager, Regulatory Affairs - Europe
The Bountiful Company —London
- Writing skills
- Bachelor's degree
- Training & development
Quick apply
Regulatory Affairs Manager
pladis —Chiswick Park Station
- Full-time
Manager Global Scientific Affairs
Sobi —London
- Full-time
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Doctoral degree
Quick apply
6d
Quality and Regulatory Manager
Advanced Healthcare Technology Ltd —Waltham Cross
- £50,000 - £60,000 a year
- Full-time
- No degree
- Organisational skills
- In-person
- Free parking
Quick apply
Regulatory Affairs Manager
Vodafone —London
- Full-time
- Analysis skills
- Leadership
- Communication skills
- Annual leave
Scientific Affairs Manager, UK - London
Rhythm Pharmaceuticals —London
- Full-time
- Doctoral degree
- Presentation skills
- Communication skills
Senior Manager Regulatory Affairs Lifecycle Management Medical Devices
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
Manager - Regulatory Affairs Lifecycle Management - Medicines
Perrigo —London
- Hybrid work
- Marketing
- English
- Continuous improvement
5d
Head of Quality Assurance and Regulatory Affairs
Qureight Ltd —London
- Full-time
- Hybrid work
- Project management
- Bachelor's degree
- Continuous improvement
- Annual leave
- Life insurance
Quick apply
12d
Regulatory Affairs Knowledge Management Capability Lead
Novartis —London
- £67,900 - £126,100 a year
- Full-time
- Hybrid work
- Leadership
6d
Medical Affairs Coordinator
Servier —Slough
- Microsoft Office
- Databases
- Administrative experience
1d
Policy Executive, Sustainability
UK Private Capital —London
- Hybrid work
- Analysis skills
- Organisational skills
- Communication skills
- Employee assistance programme
- Employee discount
Quick apply
3h
Regulatory / Compliance Manager
Sigma Consulting Group —London
- £50,000 a month
- Full-time
- Hybrid work
- Continuous improvement
- Contracts
- Manufacturing
Quick apply
Scientific Editor
WebMD —London
- Full-time
- Microsoft Office
- Bachelor's degree
- Organisational skills
Quick apply
Senior Manager – ESG and Sustainability Regulatory Legal
Pwc UK —London
- Full-time
- Hybrid work
- Analysis skills
- Presentation skills
Clinical Trials Manager
Gilead Sciences —London
- Full-time
- Management
- Doctoral degree
- Master's degree
Sr Manager, Nordics& NECAD, International Patient Engagement
Vertex Pharmaceuticals —Paddington
- Full-time
- English
- Project management
REACH Regulatory Manager
ERM Group —London
- Full-time
- English
- IT
- Leadership
Clinical Research Associate - Midlands
MSD —London
- Full-time
- English
- Microsoft Office
- Bachelor's degree

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EU Regulatory Affairs Manager

Amgen -
London

Apply Now

Job details

£48,957 - £66,237 a year

Benefits

Work from home

Full job description

United Kingdom - Uxbridge

JOB ID: R-239862 LOCATION: United Kingdom - Uxbridge ; United Kingdom - Manchester; United Kingdom - Remote; Portugal - Lisbon; Portugal - Remote; United Kingdom - London; United Kingdom - Cambridge; United Kingdom - Edinburgh WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jul. 13, 2026 CATEGORY: Regulatory

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyou’repart of something bigger,it’sbecause you are. AtAmgenour 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,manufacturingand delivering ever-better products that reachover10 million patientsworldwide.It’stime for a career you can be proud of. Join us.

EUREGULATORY AFFAIRS MANAGER

LIVE

What you will do

In this vital role you will work to ensure that Amgenacquiresandmaintainsall the requiredEUlicensesin order tosupport clinical trials for investigational medicinal products as well as marketedmedicinal products.

You will support one or more products froman EUregulatory perspective.

Strategy and Execution

Depending on business needs and experience, the role may includeEU Regulatory Leadresponsibilityfor one or more products.

Plan and manage regulatory submissions (e.g.clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans andEUregionalregulatory requirements.

Under general supervision, implement product related regulatory strategies, Regulatory Affairsprocessesand activity planningin accordance withEU regionallegislation and regulatoryrequirements. Providecontent guidance for regional regulatory documents and meetingsin accordance withglobal strategy.

Provideregulatory guidance on regional regulatory mechanisms tooptimizeproduct development (e.g.expediting FIH studies,scientificadvice,Orphan Drug,MA approvalmechanismsandpaediatricplans).

SupportEUlabel negotiation activities.

Under general supervisionparticipatein the development and execution of regional regulatory product strategies.

Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.

Regulatory Research

Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.

Perform regulatory research to obtain relevant histories,precedenceand other information relevant to regional product advancement.

Under supervision evaluate and communicate impact of relevant regional regulations,guidances, current regulatory environment and competitor labelling.

Be part of our team

We are currently looking for x3EURegulatory Affairs Managers between Portugal and the United Kingdom, joining theEUOncology or General Medicine teams, part of the Global Regulatory Affairs function in Europe.

You will be working with colleagues whoare responsible forleading the European regulatory strategies and submissions for development and marketed products from first-in human clinical trials to marketingauthorisation, 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 weseekin you as anexperienced professional, are these qualifications and skills:

Degreeeducatedandpreviousexperience in a similar role

Hands-on experience withregistration procedures intheregion, such asclinical trials,pre-MAA regulatory procedures(egscientificadvice, orphanapplicationsor PaediatricInvestigation Plans(PIPs)),MA, post-approval changes,extensionsand renewals

Experience developing regulatory strategies for products in clinical development and post-marketing phases.

Knowledge ofEUlegislation and regulations relating to medicinal products

Working with policies, procedures andSOP’s.

Strong communicationskills - both oral and written.

Ability toanticipateand prevent potential issues.

Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

Basicproficiencyin using AI tools to support day-to-day work.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being.

Growth opportunitiestolearnand 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 Plancomprisinghealth, finance and wealth, work/life balance, and career benefits

LOCATION:Flexibility to work from home with few days per month working from our Cambridge,Uxbridgeor Lisbonoffice.

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

for a career that defies imagination

In our quest to serve patientsabove 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 provideda reasonableaccommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestan accommodation.

Apply Now

Refine Your Search

regulatory affairs manager jobs in hatfield, hrt

EU Regulatory Affairs Manager

GB Sr. Manager, Regulatory Affairs - Europe

Regulatory Affairs Manager

Manager Global Scientific Affairs

Quality and Regulatory Manager

Regulatory Affairs Manager

Scientific Affairs Manager, UK - London

Senior Manager Regulatory Affairs Lifecycle Management Medical Devices

Manager - Regulatory Affairs Lifecycle Management - Medicines

Head of Quality Assurance and Regulatory Affairs

Regulatory Affairs Knowledge Management Capability Lead

Medical Affairs Coordinator

Policy Executive, Sustainability

Regulatory / Compliance Manager

Scientific Editor

Senior Manager – ESG and Sustainability Regulatory Legal

Clinical Trials Manager

Sr Manager, Nordics& NECAD, International Patient Engagement

REACH Regulatory Manager

Clinical Research Associate - Midlands

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