Regulatory Affairs Consultant
My client is a clinical stage biopharmaceutical company focused on treating rare diseases. They are seeking a Regulatory Affairs Consultant to contribute to the development and implementation of regulatory strategies for assigned development projects. This is a full time, long term engagement where you will manage cross-functional teams also interact directly with global health authorities. The ideal professional will be able to work in a fast-paced, collaborative environment and be comfortable with a high level of ambiguity.
Responsibilities:
- Contribute to the formulation of regulatory strategies and guide project teams to implement appropriate strategies for assigned products
- Represent the team at FDA and EMA regulatory agencies
- Direct the preparation and submission of INDs, NDAs, reports and correspondence to the appropriate regulatory agencies for assigned projects
- Lead regulatory affairs cross functional sub teams
- Plan and manage integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects
Knowledge and Skills:
- Minimum BS/BA in a scientific discipline required; advanced degree preferred
- Minimum 10-15 years of regulatory experience
- Must have experience working in a clinical regulatory setting
- Prior experience working directly with the FDA and ex-US agencies
- Experience with successful NDA and/or BLA filing is essential.
- Orphan drug experience a plus
Number of hours worked per week: 40 hours a week
Length of Assignment: 6 months with the possibility of extension
Position Location: Cambridge, MA