This client is an established, global biopharmaceutical company with multiple approved products and a strong pipeline. They are seeking a Global Regulatory CMC Scientist (Manager or Sr. Manager level) to develop and execute global regulatory CMC submission plans for assigned biologic development projects and/or marketed products. You will partner with cross functional teams to lead all aspects of CMC submissions including INDs, CTAs, BLAs, and supplements.
- Collaborate with multi-disciplinary teams, prepare the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports.
- Assist in preparation of risk analyses and contingency plans for CMC regulatory strategies and dossiers.
- Work with cross-functional teams for assigned projects to set objectives for HA meetings, lead interactions and oversee preparation responses.
- Provide regulatory CMC guidance to ensure development activities are aligned with relevant health authority regulations and in line with current global guidance.
- Guide manufacturing in developing data for approval of post-marketing changes.
Knowledge and Skills:
- Bachelor Degree in a scientific discipline; advanced degree preferred.
- At least 4 years of pharmaceutical industry experience, with a minimum of 2 years of experience in Regulatory CMC.
- Experience in the preparation of CMC sections for US INDs and marketing applications; experience with EU CTAs, MAAs, and/or global applications strongly preferred.
- Regulatory CMC experience with biologic programs preferred.
- Broad knowledge of global biotech CMC guidances and regulations.
- Ability to handle tasks and projects independently.
- Excellent interpersonal skills and ability to establish and maintain relationships with various intra-department, inter-department, and external third party personnel.
NOTE: Qualified candidates must be legally authorized to be employed in the United States. Client cannot support an H1B transfer.