Associate Director, Global Regulatory CMC
Delaware - United States
Seeking a highly experienced and driven Regulatory CMC leading professional to join a small group within a very established biotech-setting. We are looking for a highly qualified and confident CMC leading subject matter expert to work closely with internal and external manufacturing providers and effectively lead the teams with the development, management, and all executions of the CMC strategies for advanced programs, from clinical to commercial. This role will offer you the opportunity to work alongside impressive industry professionals while utilizing the company's very sophisticated and novel manufacturing technology platform.
- Gather all information, then develop, create, and execute the development, lifecycle management, and maintenance of the CMC submissions for all global markets while ensuring diligence, and objectives are met, all sections thoroughly completed with accurate data in a timely fashion.
- Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership and expertise within Regulatory and cross-function teams for the assigned biological products.
- Establish Regulatory CMC strategy executions to ensure compliance of CMC requirements with established regulations, guidelines, and industry; lead these strategies and share all concepts with the team.
- Strong familiarity with the US and Global regulatory guidelines for biopharmaceutical products; direct interactions with global regulatory agencies for CMC submissions and CMC-related issues; FDA, EMA, and ICH guidelines.
- Address and resolve CMC regulatory issues arising in pre-clinical, clinical, and commercial development programs.
- Direct experience assembling Regulatory applications in eCTD format. Utilize electronic systems for dossier creation and tracking.
- Hands-on Regulatory CMC and SME to liaise for CMC-specific regulatory documents and submissions, via eCTD, i.e.: INDs/CTAs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Amendments, Supplements, Annual Reports, regulatory briefing books (BB), annual update (IB), etc.
- Direct interactions with global regulatory authorities; lead meetings and support CMC regulatory activities.
- Review and provide regulatory assessments on Change Controls measures for global impact.
- Ability to identify regulatory risks and potential issues with strong expertise in the understanding of global regulations and guidance.
- Ensure global regulatory requirements and strategies are understood and communicated by project teams.
- Facilitate and manage all contacts and procedures to allow for a streamlined and organized compliance partnering with external regulatory agencies.
- Delivery of all regulatory goals and objectives through product development.
If interested in learning more, please contact Bria Gaber at firstname.lastname@example.org or (646) 430-1191 for more information.