Senior Regulatory CMC Strategy Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Establishing, coordinating, and executing global CMC regulatory strategies for specific product development and lifecycle activities.

• Offering proactive strategic advice to product-specific global regulatory and manufacturing teams to define global regulatory CMC strategies and objectives related to the development, registration, commercialization, and lifecycle management of drug products in both the United States and international markets.

• Engaging directly with the US FDA and local regulatory teams for discussions with international health authorities and agencies concerning CMC-related issues.

• Negotiating with regulatory bodies throughout the development process to ensure acceptance and approval of submissions.

• Overseeing the CMC regulatory strategy for high-quality and compliant regulatory CMC documentation (such as BLAs, INDs, CTAs, MAAs, Variations/Supplements, and other pertinent regulatory filings including meeting requests and briefing packages) for assigned products within specified timelines aligned with R&D and business objectives.

• Providing guidance on regulatory strategies, solutions to scientific challenges, and interpretation of results in light of product registration requirements alongside business needs and goals.

• Ensuring effective communication and flow of regulatory information (regulatory framework, scope, and project timelines) to all pertinent stakeholders.

• Identifying and proposing the most efficient CMC regulatory strategies to ensure initial application and lifecycle supplement/variation approvals on the first attempt.

• Working collaboratively with key functions in the preparation, review, and approval of regulatory CMC submissions as assigned to products and programs.

• In partnership with the network strategist, developing and managing timelines that support regulatory submissions, proactively identifying risks and crafting appropriate risk management solutions in collaboration with cross-functional teams.

⛳️ Requirements

• A Bachelor's degree in a relevant scientific discipline or a healthcare-related field.

• Extensive experience in global pharmaceutical/biotechnological drug development, along with a proven understanding of the global regulatory CMC landscape.

• Proven experience in authoring and managing components of regulatory submissions.

• Strong knowledge of global regulatory requirements and a demonstrated ability to serve as the primary interface with the FDA.

• Capability to support regional and local regulatory affairs teams in interactions with regional or local health authorities (e.g., EMA, PEI, AGES, PMDA, Health Canada, etc.).

• Demonstrated aptitude for developing and implementing global CMC regulatory strategies, resolving complex issues, and negotiating optimal regulatory pathways and outcomes with health authorities.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs that include medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.