San Francisco Bay Area
Competitive - Above Market Average
BD - 213
4 months ago
Senior Director Regulatory Operations
Location: San Francisco Bay Area
Type: Full Time Permanent
Salary: Excellent salary, bonus and accompanying benefits package. Relocation provided or can be 100% REMOTE!!
Exciting opportunity with a global biopharma company looking to revolutionize oncology treatment. This is a new role due to fast pipeline growth and will give the right candidate an opportunity to truly head up up the Reg Ops function and grow out the function!
The Regulatory Operations Director will be leading and ensuring the compilation of regulatory submission documentation into the eCTD dossier as well the readiness for inspection by regulatory agencies. This person will ensure high quality submissions to original INDs/CTAs, original and supplemental NDAs/BLAs/MAAs, CMC supplements, etc. This position reports to the VP of Regulatory Affairs.
- Provide Senior level expertise with the manning of the IND/NDA submission lifecycles specifically the scheduling and tracking of eCTD submissions.
- Process and publish eCTD documents for proper submission
- Development, management, and oversight of SOPs
- Lead the establishment and maintenance of a global Regulatory Information Management systems and database
- Review the QC of submissions documentation
- Performance and Resource Management – budgets, annual planning, staffing, performance standards
- BA/BS or equivalent experience, advanced degree preferred
- At least 7 years of regulatory operations publishing experience, including eCTD
- Experience with filing eINDs
- Extensive knowledge of North American submissions and industry trends for dossier preparation
- Must have a hands-on approach and a willingness to take on projects
- Understanding of eCTD, electronic publishing systems for preparing a regulatory submission
- Strategic thinker with the ability to thrive in a collaborative, fast paced environment
- Working knowledge of the drug development process
- Demonstrate ability to work effectively in a cross functional manor while applying regulatory compliance knowledge
- Proven communication skills (written/verbal) and organizational skills in regard to prioritizing tasks in a deadline-oriented environment
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at (617) 982 1238.