CrawlJobs Logo
Amgen Logo Amgen · IT - Administration

Senior Associate Regulatory Affairs

United Kingdom, Cambridge · Job Posted May 04, 2026
Apply Position
Job Link Share

Job Description

In this vital role you will support and, where appropriate, lead in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, as well as Regulatory Affairs processes and deliverables for the UK and Ireland.

Job Responsibility

  • Support and, where appropriate, lead in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, as well as Regulatory Affairs processes and deliverables for the UK and Ireland
  • Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements and support licence and clinical trials activities
  • Contribute to and execute local filing plans
  • Act as a key contact for agency interactions for an assigned portfolio of products
  • Collate, distribute, exchange and archive regulatory information with colleagues across the business
  • Participate in regulatory and affiliate process improvements initiatives
  • Review promotion and non-promotion materials to ensure compliance with local licence, company procedures and Code of Practice

Requirements

  • Degree educated
  • Experience in the management of marketing authorisations in the UK and the EU
  • Experience in/knowledge of developing and maintaining clinical trial documentation in UK and the EU (e.g. IMPDs, IMPD amendments) and ability to work with increasing autonomy
  • Knowledge and awareness of the relevant regulatory guidelines and legislation
  • Strong communication skills both oral and written
  • Organisational skills & developing or demonstrated regulatory project management skills
  • Experience with Veeva Vault

What we offer

  • Vast 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
  • Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Associate Regulatory Affairs

8 matching positions

Senior Associate Regulatory Affairs

Join our team at AMGEN Capability Center Portugal. Amgen's Regional Regulatory A...
Location
Location
Portugal , Lisbon
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree or Bachelor’s degree (scientific area) and 3 years of directly related experience
  • Demonstrated experience in clinical trial regulatory affairs
  • Previous experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) is ideal
  • Depth knowledge of EU legislation and regulations relating to medicinal products is ideal
  • Adaptability and strong English communication skills, both oral and written
Job Responsibility
Job Responsibility
  • Execute the EU regulatory strategy and EU regulatory plans
  • Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities
  • Use of Amgen systems and document management
  • Ensure and support regulatory product compliance
  • Work with policies and SOPs
  • Build effective relationships and communication paths across local and functional organizations
  • Enable efficiencies and seamless execution across the region countries
What we offer
What we offer
  • Vast opportunities to learn, develop, and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
  • Flexible work arrangements
Read More
Arrow Right

Senior Regulatory Affairs Associate - France Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
France , Remote
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in a life science discipline
  • Minimum 5 years' experience in French Regulatory Affairs, with strong understanding of French and EU regulatory requirements
  • Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
  • Comprehensive lifecycle management expertise for French submissions
  • Experience with ANSM submission processes and requirements
  • Competence in labelling management (updates, mock-up review, and print release processes)
  • Medical device knowledge advantageous, but not essential
  • Familiarity with systems such as Veeva Vault
  • Excellent organizational, time management, and interpersonal skills in a global environment
  • Proven ability to work effectively both independently and in teams
Job Responsibility
Job Responsibility
  • Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
  • Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
  • Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
  • Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
  • Serve as primary interface with ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé), industry groups, and trade associations
  • Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
  • Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
  • Monitor status of submitted regulatory activities and ensure timely completion
  • Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
  • Ensure timely submission of renewals and mandated post-approval applications
What we offer
What we offer
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right

Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
Spain , Madrid
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in a life science discipline
  • Minimum 5 years' experience in Spanish Regulatory Affairs, with strong understanding of Spanish and EU regulatory requirements
  • Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
  • Comprehensive lifecycle management expertise for Spanish submissions
  • Experience with AEMPS submission processes and requirements
  • Competence in labelling management (updates, mock-up review, and print release processes)
  • Medical device knowledge advantageous, but not essential
  • Familiarity with systems such as Veeva Vault
  • Excellent organizational, time management, and interpersonal skills in a global environment
  • Proven ability to work effectively both independently and in teams
Job Responsibility
Job Responsibility
  • Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
  • Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
  • Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
  • Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
  • Serve as primary interface with AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), industry groups, and trade associations
  • Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
  • Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
  • Monitor status of submitted regulatory activities and ensure timely completion
  • Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
  • Ensure timely submission of renewals and mandated post-approval applications
What we offer
What we offer
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right

Senior Associate - Regulatory Affairs

Let’s do this. Let’s change the world. In this vital role you will assist the US...
Location
Location
United States
Salary
Salary:
83974.90 - 113613.10 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree
  • Bachelor’s degree and 2 years of Regulatory Affairs experience
  • Associate’s degree and 6 years of Regulatory Affairs experience
  • High school diploma / GED and 8 years of Regulatory Affairs experience
Job Responsibility
Job Responsibility
  • Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
  • Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
  • Create and maintain product regulatory information and history documents through Amgen systems
  • Appropriately archive regulatory documents and agency communications
  • Collaborate with CRO’s / partners to support site initiation
  • Complete regulatory forms to support agency communications
  • Participate in GRT to support execution of regulatory strategy
  • Coordinate QC of regulatory documentation (e.g. briefing materials)
  • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
  • Assist in template development and maintenance
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Senior Associate Regulatory Affairs - Clinical Studies (CDMX)

The Local Senior Associate Regulatory Affairs provides high-level regulatory lea...
Location
Location
Mexico , Mexico City
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in health sciences or related field and experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
  • Bachelor’s degree in health sciences or related field and 2 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
  • Associate’s degree in health sciences or related field and 6 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
  • Proficiency in English, both in oral and written communication
Job Responsibility
Job Responsibility
  • Independently handle and maintain complete, accurate, and traceable regulatory documentation supporting clinical protocol approvals for initial and lifecycle management protocols submitted via DIGIPRiS, in compliance with NOM-012-SSA3-2012, applicable COFEPRIS regulations, and Amgen policies
  • Document and implement local regulatory strategies based on current health legislation, COFEPRIS guidelines, and formal regulatory agreements, ensuring alignment with approved submission pathways
  • Ensure consistency application of Good Clinical Practice (GCP) requirements across regulatory submissions and Health Authority communications
  • Systematically assess, document, and mitigate regulatory risks, including communication and escalation within Local Study Teams (LSTs) and relevant governance forums
  • Maintain detailed collaboration with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal functions to support regulatory compliance and inspection readiness
  • Define and implement local regulatory strategies based on health legislation expertise and interpretation of COFEPRIS guidelines, agreements, and evolving regulatory criteria
  • Independently assess regulatory risks and determine appropriate submission pathways and documentation approaches to support timely protocol approvals
  • Proactively assess, communicate, and mitigate regulatory risks impacting timelines and compliance during the internal LST (Local Study Team)
  • Collaborating with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal partners
  • Apply regulatory and ethical requirements, including CONBIOÉTICA guidelines, to support compliance with local Ethics Committee expectations for protocol, Inform Consent Form and other subject material or information
What we offer
What we offer
  • competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Senior Associate Regulatory Affairs - Clinical Studies

The Local Senior Associate Regulatory Affairs provides high-level regulatory lea...
Location
Location
Mexico , Mexico City
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in health sciences or related field and experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
  • Bachelor’s degree in health sciences or related field and 2 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
  • Associate’s degree in health sciences or related field and 6 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
  • Proficiency in English, both in oral and written communication
Job Responsibility
Job Responsibility
  • Independently handle and maintain complete, accurate, and traceable regulatory documentation supporting clinical protocol approvals for initial and lifecycle management protocols submitted via DIGIPRiS, in compliance with NOM-012-SSA3-2012, applicable COFEPRIS regulations, and Amgen policies
  • Document and implement local regulatory strategies based on current health legislation, COFEPRIS guidelines, and formal regulatory agreements, ensuring alignment with approved submission pathways
  • Ensure consistency application of Good Clinical Practice (GCP) requirements across regulatory submissions and Health Authority communications
  • Systematically assess, document, and mitigate regulatory risks, including communication and escalation within Local Study Teams (LSTs) and relevant governance forums
  • Maintain detailed collaboration with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal functions to support regulatory compliance and inspection readiness
  • Define and implement local regulatory strategies based on health legislation expertise and interpretation of COFEPRIS guidelines, agreements, and evolving regulatory criteria
  • Independently assess regulatory risks and determine appropriate submission pathways and documentation approaches to support timely protocol approvals
  • Proactively assess, communicate, and mitigate regulatory risks impacting timelines and compliance during the internal LST (Local Study Team)
  • Collaborating with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal partners
  • Apply regulatory and ethical requirements, including CONBIOÉTICA guidelines, to support compliance with local Ethics Committee expectations for protocol, Inform Consent Form and other subject material or information
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Regulatory Affairs Senior Associate

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States
Salary
Salary:
83974.90 - 113613.10 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master's degree
  • or Bachelor's degree and 2 years of regulatory or pharmaceutical experience
  • or Associate's degree and 6 years of regulatory or pharmaceutical experience
  • or High school diploma / GED and 8 years of regulatory or pharmaceutical experience
Job Responsibility
Job Responsibility
  • Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]
  • advisory committee meeting preparations)
  • Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL
  • Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications
  • Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables
  • perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead
  • Actively support regulatory compliance and ensure compliance of submissions to the US FDA
  • Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label
  • Coordinate collection of functional documents in support of regulatory applications
  • Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes)
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
South Africa , Bloemfontein
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in a science discipline
  • Background in clinical trial management
  • Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
  • Experience with clinical trial submissions in other Southern African Countries - preferred
  • Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
  • IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
  • Solid analysis and synthesis capability
  • Solution-oriented and problem-solving skills
  • Customer-oriented and autonomous
  • Fluency in English is a must along with the local language.
Job Responsibility
Job Responsibility
  • Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
  • Regulatory submission of Clinical Trial in South Africa
  • Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
  • May be involved in local, regional, and/or global projects
  • Fulltime
Read More
Arrow Right