Regulatory Affairs Manager

Amgen

Regulatory Affairs Manager managing licenses for clinical trials and medicinal products at Amgen. Collaborating with regional teams to ensure compliance with regulatory requirements and strategies.

Posted 6/4/2026full-timeUxbridge • 🇬🇧 United KingdomMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Work to ensure that Amgen acquires and maintains all the required licenses to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products
Support one or more products from a regional regulatory perspective
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 in accordance with national legislation and regulatory requirements
Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
Support regional label negotiation activities
Participate in the development, and execution of regional regulatory product strategies
Develop predictions for expectations and risks associated with outcomes by regulatory agencies
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, precedence and other information relevant to regional product advancement
Evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling

Requirements

What you’ll need

Scientific Degree and demonstrated experience in a similar role
Regulatory principles
Working with policies, procedures and SOP’s
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals
Knowledge of drug development
Knowledge of and experience in regional regulatory environment
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsregulatory strategiesregulatory researchdrug developmentclinical trial applicationsmarketing applicationsregulatory complianceproduct labelingrisk assessmentlegislation knowledge

Soft Skills

strong communication skillsconflict resolutionanticipation of issuesproblem-solvingteam collaborationstrategic planningcontent guidanceadaptabilityinterpersonal skillsdecision making

Certifications

scientific degree