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Senior Manager, Regulatory Affairs CMC

2 months ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time
Job Summary

We are seeking a highly skilled and experienced Regulatory Affairs Senior Manager to join our team at Gilead Sciences International, Ltd. as a CMC Regulatory Affairs Manager. This is a full-time employment position in our Cambridge, UK office, reporting to the CMC Regulatory Affairs International Affiliate Team Leader.

Key Responsibilities
  • Ensure CMC regulatory submissions meet ICH and regional/local regulatory requirements.
  • Perform CMC regulatory submissions, including clinical trial applications, amendments, supplements, marketing authorizations, post-approval variations, periodic reports, and license renewals.
  • Ensure timely discussion and negotiation with local/international health authorities regarding responses to CMC questions and work with international/local colleagues to ensure consistency of responses.
  • Perform document filing and retrieval functions as directed, or with departmental SOPs and work instructions.
  • Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to key stakeholders.
  • Perform CMC change control assessments against local regulations, guidance, and best practices.
  • Frequently interact and collaborate with colleagues outside of CMC RA to define strategy and filing plans.
  • Contribute to global filing strategy by providing local/regional expertise in CMC regulatory requirements and filing mechanisms.
  • Contribute to regulatory strategy and filings outside of the assigned market(s).
  • Contribute to local/regional/global process improvements.
  • Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices.
  • Follow knowledge sharing practices using designated knowledge management tools and processes.
  • Understand and guide relevant stakeholders and project teams on potential or actual impact of regional/local circumstances.
  • Ensure regulatory conformance and consistency for assigned products in compliance with regulatory requirements and internal procedures.
  • Ensure CMC changes with impact on labeling are communicated to the relevant stakeholders responsible for preparation and maintenance of country-specific labeling.
  • May participate or lead updating and preparing the department for minor changes in legislation.
  • May initiate and contribute to local process improvements and/or global process improvements with impact on the CMC Regulatory Affairs function or other departments.
  • May be assigned as a mentor or may support training of other colleagues on the team.
  • May serve as Product Leader or International representative on Project teams.
Requirements
  • Capable of developing and implementing optimal regulatory strategy and being a role model in the strategy execution.
  • A proven ability to co-ordinate preparation of a variety of CMC regulatory documents in collaboration with other functions.
  • Strategic prioritization and implementation of risk-based approaches that includes analyzing, prioritizing, and mitigating regulatory risks.
  • Excellent organizational skills and ability to work on and/or oversee several products/markets simultaneously and with tight timelines.
  • Excellent verbal and written communication skills focused on delivering the right message to the right audience with an ability to convey information effectively with respect and cultural understanding.
  • Effective negotiating and influencing skills based on active listening and aiming at win-win solutions.
  • Ability to think both critically in the short-term and strategically in the long term with the desired outcome of promoting solutions that address both present and future challenges.
  • Willingness to take ownership and maximize benefits of empowerment.
  • Demonstrated ability of purposeful networking and building alliances.
  • Excellent cultural awareness and appreciation. Ability to work efficiently with highly diversified individuals and groups of people.
  • Growth mindset that enables open and rapid adaptation to change and new information, or unexpected obstacles. Ability to deal effectively with pressure; and remain optimistic and persistent, even under adversity.
  • Ability to work independently or with minimal guidance.
Qualifications
  • A scientific degree with directly relevant professional experience, preferably in small molecules CMC regulatory activities (biologics experience would be an advantage).
  • Practical in-depth knowledge of ICH and EU and/or UK CMC regulatory requirements, and an understanding of current global, regional, and local trends in CMC Regulatory Affairs.
  • Proven experience with submission compilation and filing a variety of regulatory submissions including marketing authorization and technical variations of different complexity in EU and/or in UK. Direct experience with CMC submissions in the UK is preferred.
  • Experience with authoring of CMC components of marketing authorization and post approval submissions for small molecules products would be an advantage.
  • Experience representing CMC regulatory affairs on regulatory and cross-functional teams.
  • Participation and contribution to Health Authority interactions. Managing Health Authority interactions and experience with MHRA would be an advantage.
  • Drug-device combination product experience would be an advantage.