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Senior Manager, Regulatory Affairs CMC, Cambridgeshire
Client: Gilead Sciences International, Ltd.
Location: Cambridgeshire, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: d2e44a447d37
Job Views: 7
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job Description:
The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional to assume a full-time employment position in Gilead's office in Cambridge, United Kingdom in the capacity of CMC Regulatory Affairs Senior Manager, reporting to the CMC Regulatory Affairs International Affiliate Team Leader, and primarily responsible for CMC activities in United Kingdom (UK).
Job overview/summary:
The CMC Regulatory Affairs Senior Manager, while being a part of the Global CMC RA organization, serves as CMC RA Affiliate for assigned products and territories. Through partnership with Global teams and full integration in RA Affiliate, the manager will design and execute CMC RA strategies that align PDM's (Pharmaceutical, Development, Manufacturing) CMC objectives with Affiliate's business goals.
Job responsibilities:
1. Ensure CMC part of the regulatory submissions meets ICH and regional/local regulatory requirements.
2. Perform CMC regulatory submissions including clinical trial applications, amendments, supplements thereof, marketing authorizations, post-approval variations, periodic reports, and license renewals.
3. Ensure timely discussion and negotiation as necessary with local/international health authorities regarding responses to CMC questions and work with international/local colleagues to ensure consistency of responses.
4. Perform document filing and retrieval functions as directed, or with departmental SOPs and work instructions.
5. Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to key stakeholders.
6. Perform CMC change control assessments against local regulations, guidance, and best practices.
7. Frequently interact and collaborate with colleagues outside of CMC RA to define strategy and filing plans.
8. Contribute to global filing strategy by providing local/regional expertise in CMC regulatory requirements and filing mechanisms.
9. Contribute to regulatory strategy and filings outside of the assigned market(s).
10. Contribute to local/regional/global process improvements.
11. Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices.
12. Follow knowledge sharing practices using designated knowledge management tools and processes.
13. Ensure regulatory conformance and consistency for assigned products in compliance with regulatory requirements and internal procedures.
14. May participate or lead updating and preparing the department for minor changes in legislation.
15. May initiate and contribute to local process improvements.
16. May serve as Product Leader or International representative on Project teams.
Skills and Competencies:
1. Capable of developing and implementing optimal regulatory strategy.
2. A proven ability to coordinate preparation of a variety of CMC regulatory documents.
3. Excellent organizational skills and ability to work on and/or oversee several products/markets simultaneously.
4. Excellent verbal and written communication skills.
5. Effective negotiating and influencing skills.
6. Ability to think critically and strategically.
7. Willingness to take ownership and maximize benefits of empowerment.
8. Demonstrated ability of purposeful networking and building alliances.
9. Excellent cultural awareness and appreciation.
10. Growth mindset that enables open and rapid adaptation to change.
11. Ability to work independently or with minimal guidance.
Knowledge and Qualifications:
1. A scientific degree with directly relevant professional experience, preferably in small molecules CMC regulatory activities.
2. Practical in-depth knowledge of ICH and EU and/or UK CMC regulatory requirements.
3. Proven experience with submission compilation and filing a variety of regulatory submissions.
4. Experience with authoring of CMC components of marketing authorization and post-approval submissions.
5. Experience representing CMC regulatory affairs on regulatory and cross-functional teams.
6. Participation and contribution to Health Authority interactions.
Equal Employment Opportunity (EEO): It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit select and employ the most qualified persons available for positions throughout the Company.
For Current Gilead Employees and Contractors: Please log onto your account to apply for this job.
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