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Senior Manager Regulatory Affairs - CMC
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Green Key Resources
Garrett Park, MD (In Person)
Full-Time
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Job Description
Senior Manager Regulatory Affairs - CMC at Green Key Resources Senior Manager Regulatory Affairs - CMC at Green Key Resources in Garrett Park, Maryland Posted in 3 days ago.
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 e 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 us
Type:
full-timeJob Description:
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 e 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 us