Lead Regulatory Affairs Director

2 months ago

Cambridge, United States Aspartes Pharmaceuticals Full time

**Position Overview**:
We are seeking an exceptionally talented lead Regulatory Affairs director with a high level of experience in the rare/ultra-rare disease space. The role is centered around providing key insight and regulatory input for the development of a small molecule treatment for a rare-pediatric CNS disorder on the US market.

**Responsibilities**:

- Providing early and late-stage regulatory leadership in the development and management of a rare pediatric disease product.
- Preparing, reviewing and submitting key regulatory documents and assessing opportunities for various applicable designations (Breakthrough, Fast-Track, RPD, ODD etc.) as a means to expedite the clinical trial and review process.
- Serving as the primary point of contact for strategic regulatory input on FDA meetings and negotiating with key regulatory agencies (FDA and Health Canada) to resolve and manage key regulatory hurdles.

**Requirements**:

- In-depth knowledge of Regulatory Affairs strategies with an executive level of experience in the biotechnology and pharmaceutical industry with a focus on rare/ultra-rare disease and orphan drug development.
- Thorough understanding of FDA and Health Canada drug development regulations and guidelines.
- Experience in interacting with regulatory authorities as needed for all aspects pertaining to drug development and regulatory approval.
- High level of experience in managing Breakthrough Therapy, Fast-Track, and Rare Pediatric Disease designation requests as a means of expediting the clinical trial process.
- Ability to negotiate with regulatory agencies to resolve key regulatory issues.
- Familiarity in organizing Expanded Access Programs, and implementing REMS strategies for products.

Pay: $100,000.00 - $200,000.00 per year

Experience level:

- 10 years

Schedule:

- 8 hour shift

Ability to Relocate:

- Cambridge, MA 02139: Relocate before starting work (required)

Work Location: In person

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