Senior Manager Regulatory Affairs - CMC

A commercial‑stage rare‑disease biopharmaceutical company is hiring a Senior Manager, Regulatory Affairs (CMC) to lead regulatory strategy and submissions for products across development and post‑approval stages. This is a high‑impact role supporting global filings, CMC strategy, and Health Authority interactions for a diverse portfolio spanning small molecules and biologics.

The Impact You’ll Mak

eIn this role, you will serve as a key regulatory leader responsible for shaping and executing CMC regulatory strategy across assigned programs. You will

• :Lead the planning, preparation, and submission of global regulatory dossiers (INDs, NDAs/BLAs, IMPDs, MAAs, and lifecycle submissions
• )Drive strategic regulatory decision‑making and assess the impact of manufacturing, analytical, and quality change
• sServe as the primary liaison with global Health Authorities for assigned product
• sProvide regulatory and scientific support for analytical and bioanalytical method development, validation, and stability program
• sStay current on evolving regulations and agency expectation
• sTake on additional responsibilities as programs grow and evolv

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What You Bri

• ngMaster’s degree with 10+ years OR doctorate with 5+ years in CMC Regulatory Affai
• rsStrong experience with regulatory strategy, application maintenance, and eCTD authori
• ngBackground in manufacturing and/or QA/QC within pharma or biote
• chExpertise drafting CMC sections in eCTD and evaluating manufacturing changes (site transfers, process/equipment change
• s)Knowledge of API and drug product manufacturing for small molecules and/or biologi
• csFamiliarity with global regulatory requirements (FDA, EMA, Health Canada) across dosage forms (tablets, capsules, injectables, oral solutions, ophthalmic
• s)Experience working with global CMOs and CR
• OsUnderstanding of GLP/GMP; prior inspection experience preferr
• edAbility to interpret scientific data, identify issues, and drive solutio
• nsExperience with Veeva is a pl