Senior Regulatory CMC Consultant
My client is a mid-sized biopharmaceutical company focused on treating rare diseases world-wide. They are seeking a Senior Regulatory Consultant to produce and edit CMC regulatory documents for submission to regulatory agencies with emphasis on the FDA and EMA. This is a long term engagement where you have the ability to summarize technical study reports provide data in a manner that supports the strategic intent of the regulatory submission. The ideal professional will be able to work in a fast-paced, collaborative environment and be comfortable with a high level of ambiguity.
Responsibilities:
- Assist with the planning, writing, and review of CMC sections of pre-INDs, INDs, IMPDs. NDAs, MAAs, annual reports, amendments, supplements to ensure a high quality regulatory submission and approval
- INDs, IMPDs. NDAs, MAAs, annual reports, amendments, supplements to ensure a high quality regulatory submission and approval
- Manage timelines in cooperation with project management, Operations, SMEs and Regulatory Operations to ensure on time regulatory submissions
- Ensure accurate and timely completion/delivery of information and review of regulatory submissions
- Assist in review of manufacturing change controls
Knowledge and Skills:
- Minimum of a MS/PHD in a scientific discipline
- Minimum of 10 years pharmaceutical industry experience and 3-6 years of relevant regulatory CMC biotech/pharmaceutical industry experience
- Must have experience working on CMC section filings of pre-INDs, INDs, IMPDs, CDAs and NDAs/MAAs
- Global CMC Section experience a plus
- Well-developed writing skills
Number of hours worked per week: 30-40 hours a week (on-site)
Length of Assignment: 6 months with the possibility of extension
Position Location: Cambridge, MA