Director Regulatory Affairs
My client is a clinical growing, clinical stage drug development company based in the Cambridge area. Their technology platform will harness new treatments to cure various forms of cancers and metabolic disorders. They are in need of a Director of Regulatory Affairs to manage the preparation of global regulatory submissions including IND amendments, CTAs, and responses to regulatory agency questions to support Phase 3 development. In this role, you will be the right arm of the Vice President of Regulatory Affairs, with an opportunity to jump in to an entrepreneurial environment and lead a novel, first in class program with FDA and agencies worldwide. This is a role in which you will interact with the external agents who represent each agency and is a tremendous opportunity for someone who is interested in driving global filings for novel therapies.
Responsibilities:
- Propose and design well-informed regulatory strategies for the US and EU
- Assist in the preparation for regulatory agency meetings (Pre-IND, End-of-Phase 2,
Type C)
- Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages
- Establish relevant processes and procedures to support the Regulatory Affairs function activities
- Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements
- Ensure compliance with regulatory requirements
Knowledge and Skills:
- BS in life sciences required; advanced degree preferred
- Minimum 8-10 years industry experience with a minimum of 7 years’ regulatory affairs development experience
- Experience managing global CTA submissions
- Demonstrated evidence of writing regulatory documents (Module 1, Module 2, briefing packages)
- Knowledge of FDA and ICH regulations and guidelines a must
- Knowledge of EU and Health Canada regulations and guidelines desirable
- Knowledge of drug development
- Excellent written and oral communication skills
- Excellent interpersonal skills