Salary: $150,000 - $170,000/year
Sr. Manager Regulatory Affairs CMC
Remote, United States
Job Description:
One of the most sophisticated and high level biopharmaceutical companies is hiring for a remote Senior Manager of Regulatory Affairs CMC. Known for their cutting edge research and development of immuno-oncology, you will have a key role in advancing their well-developed pipeline in a variety of different diseases ranging from multiple Phase III projects to the discovery phase. If you have strong biologics CMC experience and enjoy being part of a state-of-the-art team, you might be right for this role.
Responsibilities:
- Contribute to the creation and evaluation of CMC materials for initial INDs, annual reports/DSURs, IMPD, and IMPD amendments, ensuring meticulous precision in CMC content and strategic congruence with regulatory objectives.
- Keep tabs on external regulatory CMC guidance and modifications to pharmacopeia standards, delivering timely monitoring and reporting.
- Facilitate the development and assessment of CMC sections within applications and revisions, ensuring comprehensive alignment with regional guidelines and adherence to submission standards.
- Take an active role in overseeing the Chemistry, Manufacturing & Controls (CMC) components of biologic products at different stages of development, collaborating with interdisciplinary teams to generate regulatory submissions of exceptional quality that align with the strategic direction of product development.
Qualifications:
- Possess 5+ years of experience in a CMC capacity focused on biologics, encompassing areas such as Process Development, Analytical, Manufacturing, QC, or QA, within the biotechnology sector.
- Master's degree in Regulatory Science and/or possessing RAC certification is highly advantageous.
- Demonstrate an understanding of CMC-related advancements specific to monoclonal antibodies, accompanied by over one year of experience in Regulatory CMC.
- Possess familiarity with validated Regulatory Information Management systems, including but not limited to Veeva RIM or other Veeva modules (such as Veeva Vault), as a desired skillset.
- Familiarity with cGMP and diverse stages of the product lifecycle is preferred.
Benefits
- Competitive Compensation
- Health and wellness benefits
- Retirement plans
- Stock Options/Equity
If you think you would be a good fit for this role, please reach out to Brandon.Smith@epmscientific.com
