Director Jobs

About The Position

Requirements

• Bachelor’s degree required; advanced degree (MS, PhD, PharmD, or equivalent) preferred in life sciences, chemistry, biochemistry, or a related field.
• Experience in cell therapy (allogeneic and/or autologous). Experience across both allogeneic and autologous platforms is a plus.
• Late-stage and/or commercial CMC regulatory experience is required.
• Demonstrated experience with BLA and/or MAA submissions strongly preferred.
• Proven track record as a strong, independent author of CMC regulatory submissions (Module 3/CTD), with the ability to produce clear, scientifically rigorous documents with minimal supervision.
• Hands-on experience with lifecycle management CMC activities, including post-approval supplements, comparability protocols, commercial manufacturing changes, and annual reports.
• Working knowledge of late-stage and commercial CMC operations and development activities, including process characterization and validation, analytical method validation, stability study design, and scale-up/tech transfer as they relate to regulatory strategy and submissions.
• Experience with ex-US regulatory submissions required, with specific experience submitting to and interacting with EMA (MAA, Scientific Advice, post-approval variations) and ANVISA.
• Familiarity with additional global health authorities (e.g., Health Canada, PMDA) is a plus.
• Experience supporting formal health authority meeting requests and interactions with FDA, EMA, and/or ANVISA, including preparation of meeting packages, briefing documents, and agency responses.
• Strong knowledge of global CMC regulations and guidelines applicable to biologics and cell/gene therapy, including FDA regulations (21 CFR), EMA guidelines, ICH guidelines (Q5-Q12 series), and other ex-US jurisdiction requirements.
• Excellent written communication skills; demonstrated ability to independently author, review, and edit regulatory documents to the highest scientific and editorial standards.
• Strong organizational skills and attention to detail; ability to manage multiple priorities and deadlines simultaneously in a fast-paced, dynamic environment.
• Collaborative and effective cross-functional partner with Quality, Process Development, Manufacturing, Clinical, and CMC leadership teams.

Nice To Haves

• Advanced degree (MS, PhD, PharmD, or equivalent) preferred in life sciences, chemistry, biochemistry, or a related field.
• Experience across both allogeneic and autologous platforms is a plus.
• Demonstrated experience with BLA and/or MAA submissions strongly preferred.
• Familiarity with additional global health authorities (e.g., Health Canada, PMDA) is a plus.
• This role has no direct reports initially; however, the successful candidate will be expected to provide informal mentorship and contribute to the development of junior regulatory staff over time.

Responsibilities

• Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory filings, including BLAs, MAAs, IMPDs, INDs, and associated amendments and supplements.
• Author clear, scientifically rigorous Module 3/CTD dossier content across drug substance, drug product, and analytical sections.
• Support commercial lifecycle management activities, including authoring and reviewing post-approval submissions, comparability protocols, CMC supplements, labeling updates, and annual product reviews for cell therapy (allogeneic and/or autologous) products.
• Contribute to ex-US regulatory submissions with a primary focus on EMA (MAA, Scientific Advice, post-approval variations) and ANVISA, ensuring dossiers meet jurisdiction-specific formatting and content requirements.
• Prepare and coordinate formal health authority meeting packages, including Type A/B/C meetings with FDA, Scientific Advice requests with EMA, and formal interactions with ex-US jurisdictions.
• Author meeting briefing documents, slide decks, and high-quality written responses to agency questions.
• Partner with Process Development, Analytical Development, Manufacturing, and Quality teams to provide CMC regulatory input on late-stage development activities and study designs, including process characterization, comparability studies, analytical method validation, and stability programs.
• Compile, organize, and author regulatory documents; prepare high-quality written responses to health authority queries and deficiency letters from FDA and ex-US jurisdictions.
• Maintain current knowledge of evolving global CMC regulations and cell and gene therapy-specific guidance documents (FDA, EMA, ICH, ANVISA); contribute to internal regulatory intelligence and best-practice initiatives.
• Track and manage regulatory commitments, submission timelines, annual reporting and post-approval reporting obligations to ensure timely and complete compliance across all active programs.

Benefits

• Medical
• Dental
• Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Bonus.ly recognition program