Amgen Regulatory Affairs Manager - CMC in Uxbridge, United Kingdom
Regulatory Affairs Manager, CMC
Amgen Intercontinental Regulatory CMC team is looking for an experienced Regulatory Affairs Manager to join a growing team. You will work in close collaboration with the Senior Manager Regulatory CMC, regional CMC leads as well as country local Regulatory representatives on ensuring efficient execution of the regional submission plans.
If you are looking for your next career step within CMC Regulatory field and want to be part of our mission - To serve patients - which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/
Our CMC Regulatory Affairs Team:
The Regulatory Affairs CMC team develops regulatory strategy and manages the execution of the submission plans for countries located in Latin America, Middle East and Africa, Turkey, Canada and South Africa for a portfolio of innovative and biosimilar products, both small molecules and biologics. The teams provide guidance to the Global teams, Regulatory and Operations, and to the country Local Regulatory Representatives on the submission plans and coordinates the activities to ensure robust and compliant submission content and on-time regulatory submissions.
Regulatory Affairs Manager CMC role overview:
In this role, you will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the intercontinental region.
Oversee and review the preparation of M2 and 3 CMC components of filings
Accountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals and responses to questions across assigned products and countries.
Authoring and coordinating responses to questions across assigned products and countries.
Gathering, consolidating and analysing regulatory intelligence for Intercontinental region and support its application to product-specific activities
Project management of submissions and monitoring status of applications
Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered
Provides guidance for regulatory assessments of change control requests
Provide regional/country, product & regulatory expertise and clarification on regional CMC RA requirements
Qualifications and required experience:
Bachelor's degree or equivalent
CMC- specific regulatory knowledge & experience within biotechnology
Direct experience with EU and EM market applications - MAAs or variations
Good understanding and direct experience of ex US filings
Creation and execution of regional regulatory strategies - MAAs or variations
Proven experience and skills needed:
Proven experience of pharmaceutical/biotechnology or medical device industry preferably within EU and Emerging Markets (MEA, LATAM, Canada, Turkey, South Africa, Canada)
Project management skills with ability to work well with others in demanding situations
Strong communication skills - oral and written Organizational skills
Strong computer skills, including word processing, database document repository and project Management software
Strong team player with a commitment to customer service and relationship building
Ability to work in a fast-paced environment
Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products
Location : Uxbridge
Remuneration: Competitive salary & comprehensive benefits package including bonus scheme
About our company:
Amgen is one of the world's largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.