Regulatory Affairs Manager - CMC
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Amgen is one of the world’s leading independent biotechnology companies, with global revenues in excess of $18 billion and over 18,000 employees. 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.
The Regulatory Professional 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 (Middle East, Turkey, Africa, Latin America and Canada).
Responsibilities will include:
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
Skills / Competencies:
In-depth experience of pharmaceutical/biotechnology or medical device industry
Strong record of related experience within Regulatory Affairs (min 5 years)
Strong communication skills - oral and written Organizational skills
Strong interpersonal skills
Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
Strong computer skills, including word processing, database document repository and project management software
Strong team player with a commitment to customer service
Attention to detail
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
Time and project management skills
Drive for results
Ability to work in a fast paced environment
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
Management of intelligence
Expanding knowledge of related disciplinary areas
Understands the core business process and purpose of the functional area in Amgen’s commercialization process
Developing own project management techniques
Enhances own knowledge through understanding business trends and objectives
Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products
BS (MS or higher preferred) life sciences, engineering or related field
Amgen is an Equal Opportunity employer.