Centessa Pharmaceuticals · 1 month ago
Executive Director, Regulatory CMC
United States
Full-time
Remote
Director/Executive
$285K/yr - $370K/yr
15+ years expCentessa Pharmaceuticals plc is a new kind of pharmaceutical company with a focus on data-driven decision-making and an asset-centric R&D model. The Executive Director, Regulatory CMC will lead global CMC regulatory activities, ensuring compliance with health authorities and driving regulatory strategies throughout drug development and lifecycle management.
BiotechnologyPharmaceutical
Responsibilities
Provide overall regulatory CMC strategy for drug development programs and life cycle management, ensuring alignment with corporate objectives and timelines
Serve as a spokesperson and trusted liaison with FDA and other health authorities, leading negotiations and presenting CMC positions effectively
Develop de-risking strategies for CMC development, assess change controls, and identify opportunities to accelerate development in a dynamic environment
Lead creation and execution of comprehensive CMC development plans for new products, ensuring integration with Technical Operations and external partners
Partner with supply chain, clinical operations, and manufacturing teams to ensure readiness and compliance for clinical and commercial supply
Oversee preparation and quality of all CMC regulatory submissions (INDs, BLAs, MAAs, DMFs, IMPDs, amendments, annual reports), providing strategic direction and ensuring global compliance
Drive the development and implementation of departmental policies, SOPs, and best practices to support scalability and operational excellence in a growing organization
Interpret and communicate regulatory CMC requirements and expectations to internal teams and external partners to ensure program objectives are met
Contribute to corporate initiatives aimed at improving regulatory standards, systems, and processes across the organization
Qualification
Required
Master's degree in chemistry, pharmaceutical sciences, or a related scientific field (PharmD or PhD preferred)
Minimum 15 years in the pharmaceutical industry, including at least 7 years in Regulatory CMC
Demonstrated experience across early-stage, late-stage development, and life cycle management for small molecule products
Comprehensive understanding of FDA, EMA, and ICH CMC guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP)
Proven experience preparing and submitting CMC regulatory documents (e.g., INDs, IMPDs, CTAs, BLAs, MAAs) and leading successful interactions with health authorities such as FDA and EMA
Track record of developing and executing CMC regulatory strategies, balancing near-term objectives with long-term goals
Strong leadership skills with the ability to work effectively in a matrixed environment; excellent verbal and written communication skills to articulate regulatory viewpoints to diverse audiences
Ability to thrive in a fast-paced, collaborative environment and comfortable with both strategic planning and hands-on execution
Benefits
Discretionary annual bonus
Participation in our equity program
401(k) plan
Company-sponsored medical
Dental
Vision
Life insurance
Generous paid time off
Health and wellness program
Company
Centessa Pharmaceuticals
Centessa Pharmaceuticals is a next-generation biopharmaceutical company that aims to reshape the traditional drug development process.
51-200 employees
H1B Sponsorship
Centessa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.12BKey Investors
Oberland Capital
2025-11-11Post Ipo Equity· $250M
2024-09-11Post Ipo Equity· $225M
2024-04-23Post Ipo Equity· $100M
Leadership Team
John Crowley
Chief Financial Officer
Gregory Weinhoff
Chief Business Officer
Recent News
2026-01-05
2025-12-14
Company data provided by crunchbase