Regulatory Affairs Consultant
My client is a clinical stage biopharmaceutical company focused on rare disease. My client is seeking a Regulatory Affairs Consultant to support development thru commercial activities related to rare disease programs. This is a short term engagement and it will be approximately 30-40 hours per week. The ideal professional will be able to work in a fast-paced, collaborative environment with a high level of ambiguity.
Responsibilities:
- Accurately interpret and reflect regulatory and Corporate guidelines
- Plan and manage integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects
- Represent the regulatory team at FDA and EMA agencies for all assigned products
- Oversee the planning and conduct of meetings with regulatory agencies as appropriate
- Initiate and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products
- Provide company with current and proposed regulatory, scientific and pertinent legal issues (i.e., external meetings, workshops and conferences)
- Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review
Knowledge and Skills:
- Minimum BS/BA required
- Must have experience filing NDA/MAA/CTA
- International Regulatory Affairs experience a plus
- Must have experience working on full lifecycle programs
Number of hours worked per week: 30- 40 hours a week
Length of Assignment: 4-6 months
Position Location: Cambridge, MA