Job Summary
A biopharmaceutical medical research firm has a current position open for a Remote Regulatory Affairs CMC Senior Manager in Frederick.
Core Responsibilities Include:
- Leading and supporting the development of sound regulatory strategies for CMC and facilities related topics
- Leading and supporting the regulatory activities related to CMC and/or facility changes
- Strategizing on deliverables to ensure M3 content meets regulatory requirements and projected business timelines
Must meet the following requirements for consideration:
- Advanced scientific degree (i.e. MD, PharmD, PhD)
- 7+ years of experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry
- Organizational skills – detail oriented and can deal with frequent changes in product activity
- Willingness to think outside of the box and adapt best practices to our growing environment
- Provide leadership to rapidly adapt strategy to unanticipated changes
- Ability to adapt in a constantly evolving environment
