Title: Associate Director/Senior Manager Regulatory Affairs (REMOTE)
Summary:
An exciting, fully remote opportunity with a Boston based Biotech. They are seeking a qualified, passionate candidate to aid in leading the Regulatory Affairs team, and develop the Regulatory strategy.
Responsibilities:
- Overall management of Global Regulatory strategies of products through clinical development, as well as performing leadership tasks within the Regulatory team
- Contribute and head up the development/strategy of Regulatory document submissions to CTAs, INDs, NDAs/BLAs, and MAAs
- Working knowledge of U.S. Regulatory requirements for prescription drugs
- Directly correspond with the FDA and EMA on critical Regulatory documents with involvement in prescription drug approval
Qualifications:
- 5+ years of Regulatory Affairs professional experience
- 5+ years of pharmaceutical prescription drug experience
- Regulatory Affairs PHD, PharmD, or MS preferred
- Well versed in supporting and leading interactions with Regulatory authorities
