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Director, CMC Regulatory Affairs

19 minutes ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Jade Biosciences

Jade Biosciences

Jade Biosciences is focused on developing innovative therapies aimed at redefining the standard of care for patients with autoimmune diseases, with a clinical pipeline that includes its lead candidate, JADE101, which is designed to inhibit the cytokine...

Pharmaceuticals
Founded 2024
View All Jobs 3

Description

  • Develop and implement global CMC regulatory strategies for biologic and combination products.
  • Prepare and manage CMC submissions, briefing documents, and health authority meeting packages, including INDs, CTAs, BLAs, MAAs, and post-approval filings.
  • Serve as the CMC Regulatory lead on cross-functional project teams.
  • Support health authority interactions and responses to regulatory questions.
  • Provide regulatory guidance on manufacturing, analytical, quality, and lifecycle topics.
  • Assess the regulatory impact of manufacturing and lifecycle changes and develop risk mitigation strategies.
  • Collaborate with internal teams and external partners to support development and commercialization.
  • Stay current on regulatory trends, guidance documents, and changes to global CMC requirements.
  • Support product release, investigations, inspections, and SOP reviews.

Requirements

  • Bachelor’s degree in a scientific discipline such as Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
  • Minimum of 10 years of experience in Regulatory Affairs, CMC, or related pharmaceutical or biotechnology functions, with significant biologics experience.
  • Proven experience developing and executing global CMC regulatory strategies for biologics across clinical and commercial stages.
  • Strong knowledge of global CMC regulatory requirements and experience with INDs, IMPDs, CTAs, BLAs, MAAs, and post-approval submissions.
  • Solid understanding of biologics and combination product development and manufacturing, including analytical methods, process validation, comparability, specifications, and stability.
  • Experience supporting health authority interactions, including regulatory meetings and responses to agency questions.
  • Ability to assess regulatory impacts of product, process, manufacturing, and lifecycle changes and develop appropriate regulatory strategies.
  • Strong leadership, project management, communication, and cross-functional collaboration skills.
  • Experience with biologics and combination products, including prefilled syringes and autoinjectors, is preferred.

Benefits

  • Fully remote role.
  • Periodic travel to team and company events.
  • Anticipated salary range of $210,000 to $235,000.
  • Equal Opportunity employer.
  • E-Verify participation for U.S. work authorization verification.

Interested in this position?

Apply directly on the company website

Apply Now

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