Associate Director, Analytical Development & Quality Control
Listed on 2026-10-09
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Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Role:
Senior Quality Control Lead overseeing analytical development and QC activities for late-stage oligonucleotide programs, supporting process validation, commercial readiness, and regulatory submissions.
Responsibilities: manage AD&QC activities with CDMOs, develop and maintain analytical methods and specifications across product lifecycle, author/review regulatory documents (IND, IMPD, NDA, MAA), and support GMP manufacturing readiness. Acts as SME during inspections and audits, ensuring compliance with global regulatory standards (ICH, FDA, EMA, cGMP). Collaborates across R&D, QA, Regulatory, and manufacturing teams to ensure quality and compliance.
RequirementsRequirements:
Ph.D. in Organic/Analytical Chemistry or related field, min. 6 years in AD&QC within biotech/pharma, extensive experience with oligonucleotide QC, regulatory filings, and cGMP regulations.
Preferred: knowledge of PMO/PTMO, experience with late-stage, commercial oligo manufacturing, and regulatory submission expertise.
High ValueHigh Value: oligonucleotide therapeutics (DMD, DM1), late-stage/production, regulatory documentation, GMP compliance, cross-functional coordination.
LocationLocation:
Remote US, preference for New England candidates with periodic travel to Boston.
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