A career within Gilead’s lean, fast paced regulatory team will give you the opportunity to grow your experience quickly. Working with an experienced team of regulatory leaders each role within the Regulatory team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients quickly.
As a result of a strong drug pipeline Gilead’s Regulatory team in Cambridge is currently looking for a Manager/Senior Associate Regulatory Affairs CMC. This role will provide CMC regulatory support for Gilead’s investigational and commercial products across Europe, with a focus on supporting products in HIV, Inflammatory Diseases and Emerging Viral Diseases therapy areas, including Lenacapavir, Veklury and Jyseleca.
This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of territories with diverse regulatory requirements and processes and an evolving regulatory landscape.
Under general direction, the Manager/Senior Associate RA CMC will be responsible for;
- Preparation and/or coordination of regulatory submissions for Gilead’s investigational and commercial products in the EU and International markets, primarily supporting the HIV, Inflammatory Diseases and Emerging Viral Diseases programs. This could include support of major MAA submission filings in EU, Switzerland and Israel.
- Preparation of high-quality chemistry, manufacturing and controls (CMC) documentation to support original MAAs, variations and renewals.
- Preparation of Quality components for investigational medicinal products to support clinical trial applications and amendments in the EU and International markets.
- Co-ordination of responses to CMC questions from regulatory authorities.
- Providing input on CMC regulatory requirements to manufacturing and pharmaceutical development groups for clinical trials, new product registrations and post-approval changes.
- Providing regulatory assessments for proposed changes to investigational and commercial products.
- Maintaining an up-to-date awareness of CMC regulatory requirements for applicable territories and communicating key intelligence to the organization in a timely manner.
- Initiating or contributing to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
The Manager/Senior Associate RA CMC will work closely with international colleagues to ensure consistency with responses to questions, and with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for CTAs, marketing applications, variations and renewals.
Knowledge, Experience & Skills
- Typically requires a BA or BS degree in a relevant discipline and relevant experience in CMC Regulatory Affairs.
- Experience in the preparation and maintenance of CMC components for regulatory submissions.
- General understanding of CMC regulatory requirements and quality guidelines, including ICH and regional requirements.
- Excellent organization skills and ability to work on several simultaneous projects with tight timelines.
- Excellent verbal and written communication skills and interpersonal skills.
- Regulatory Affairs CMC experience of investigational and commercial products.
Relevant industry experience is advantageous