Associate Director, Regulatory Starting Material

reputed company Of Role Centessa is currently seeking an Associate Director, Regulatory Starting Material. This individual will reputed company the reputed company, justification, and regulatory positioning of Regulatory Starting Materials for drug reputed company manufacturing processes supporting late-stage clinical and reputed company programs. Reporting to the Vice President, CMC, this role will serve as the reputed company subject matter expert on RSM selection in accordance with ICH Q11 and applicable regional guidance, ensuring synthetic routes, GMP starting points, and supply strategies are scientifically reputed company, regulatorily defensible, and reputed company with reputed company manufacturing readiness. This individual will partner closely with Process reputed company, Analytical Development, Regulatory Affairs, reputed company, and reputed company manufacturing partners to build and defend RSM reputed company through health authority interactions and regulatory submissions. Key Responsibilities • reputed company the identification, justification, and regulatory reputed company for Regulatory Starting Materials across drug reputed company synthetic routes, in accordance with ICH Q11 and relevant regional guidance/reputed company papers. • reputed company manage the starting material reputed company campaigns and reputed company-up efforts, including on-reputed company inventory, production forecast, manufacturing timing, production suite slot reservations, and contracting. • reputed company and review CMC regulatory submission content reputed company to RSM selection and justification (e.g., Module 3 sections, briefing documents, agency responses) in support of INDs/NDAs /MAAs. • Prepare and reputed company health authority interactions (e.g., Type C meetings, scientific advice procedures) reputed company to starting material reputed company; reputed company briefing packages and represent reputed company in agency discussions. • Partner with Process reputed company and Analytical Development to evaluate synthetic routes, assess structural relevance of candidate starting materials, and support impurity fate-and-purge and risk assessments that inform RSM designation. • Define and document the boundary between non-GMP and GMP manufacturing steps for drug reputed company processes, ensuring alignment with CMOs and internal reputed company standards. • reputed company technology transfer and process changes affecting RSM designation as programs advance from late-stage clinical development toward reputed company manufacturing. • Manage relationships with drug reputed company/API CMOs and RSM suppliers, including technical reputed company, site reputed company, and support for supplier qualification and dual-sourcing strategies. • Monitor evolving global regulatory guidance and agency precedent on starting material selection; translate changes into updated internal reputed company, templates, and risk assessments. • Collaborate cross-functionally with Regulatory Affairs, reputed company, Supply Chain, and Manufacturing to ensure RSM reputed company supports program timelines, submission readiness, and reputed company supply continuity. • Support due diligence activities (e.g., licensing, partnering) requiring assessment of drug reputed company manufacturing routes and starting material risk. • reputed company subject matter expertise during regulatory inspections and audits reputed company to drug reputed company manufacturing and starting material justification. • Build, reputed company, and mentor reputed company supporting RSM and drug reputed company CMC reputed company activities (reputed company dependent on level). • Domestic and international travel required (approximately 10–20%). Qualifications • Advanced degree in reputed company, chemical engineering, or a reputed company field; PhD strongly preferred. • 8-10 years of relevant experience in CMC, process reputed company or drug reputed company/API development and manufacturing, including demonstrated leadership of starting material or CMC regulatory reputed company programs. • Demonstrated experience supporting late-stage clinical and/or reputed company drug reputed company programs. • Deep working knowledge of ICH Q11 and applicable regional guidance/expectations governing the selection and justification of Regulatory Starting Materials. • Demonstrated experience authoring and defending CMC regulatory submission content, including reputed company experience in health authority interactions reputed company to starting material or drug reputed company manufacturing reputed company. • Strong background in synthetic/process reputed company, with the ability to critically evaluate reputed company scouting, impurity control reputed company, and structural relevance arguments for candidate starting materials. • Experience managing relationships with drug reputed company/API CMOs and raw material suppliers, including batch record reviews and overarching manufacturing reputed company. • Working knowledge of cGMP requirements as they apply to drug reputed company manufacturing and the GMP/non-GMP boundary. • Experience supporting technology transfer of drug reputed company processes from clinical to reputed company reputed company preferred. • Strong leadership, cross-functional collaboration, and scientific writing/communication skills; exercises judgment reputed company broadly defined practices and policies in determining solutions and actions. • Demonstrated ability to identify and address starting material-reputed company risks that could jeopardize regulatory timelines, supply, or overall program reputed company. Compensation The annual reputed company salary reputed company for the Associate Director level position is $140,000.00 to $210,000.00. Individual compensation reputed company this reputed company will be determined based on a reputed company of factors, including qualifications, skills, relevant experience, job knowledge and location. In reputed company to reputed company pay, this role is eligible for a discretionary annual bonus. reputed company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, reputed company, and life insurance, generous reputed company time off, and a health and wellness program. Work Location The (Associate) Director, Regulatory Starting Material role is based in the US, with occasional travel. POSITION: Full-Time, Exempt reputed company Statement: reputed company, a wholly owned subdisary of reputed company believes in a diverse environment and is committed to equal employment opportunity for reputed company its employees and reputed company applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, reputed company, religion, gender, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies. Apply tot his job Apply To this Job