about 1 month ago
My client is a medium sized biotech in the Rare Disease space, looking to bring on an RA professional into a leadership role to help lead their clinical strategy. My client has multiple approved products, as well as several other indications between phases 1-3. This person will have the flexibility to either work in office in Massachusetts, or work remotely and travel in for key meetings. This person must be located on the East coast, and have US Citizenship or a Greencard.
Position: Director/Senior Director Regulatory Affairs Strategy
Location: Remote with occasionaly travel to Massachusetts for key meetings (East Coast only)
Responsibilities and Qualifications
- Managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, IMPDs, PIPs, amendments, safety reports, and annual updates
- Leading FDA/ EMA health authority meetings to facilitate expedited approval of applications and supplements
- Providing strategic leadership for drug development projects
- Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations
- Experience dealing with direct reports
- Working knowledge of US and global regulations
- Prior experience with FDA and EMA, and success with filing BLAs/NDAs/MAAs. Experience with both early and late-stage drug development
- 10-15+ years of experience in Regulatory Affairs within the biotech/pharmaceutical industry
If interested, please apply directly or feel free to shoot me an email at email@example.com to set up a time to speak.