Support and lead in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements
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

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

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

Senior Associate, Regulatory Affairs

Key skills