Director Regulatory Affairs Strategy

Jersey City, New Jersey (Hybrid Role)

Contract

Job Description

We have an urgent requirement for a Director of Regulatory Affairs Strategy.

Exclusive Leading Pharma firm who specializes in the marketing and distribution of exclusive range of ADHD medications with unique brand identities.

The ideal candidate will have a strong background in regulatory affairs and strategy, with a focus on small molecules. The candidate should have a strategic mindset and excellent project management skills, with the ability to work collaboratively across different departments to ensure successful product development and regulatory submissions.

Director Regulatory Affairs Strategy with Small molecules

Roles and Responsibilities

- Develops and executes strategies for the preparation and submission of IND and NDA applications.

- Takes the lead in planning, writing, and reviewing all regulatory submissions, including pre-IND, original IND, 505(b)1&2 NDAs, as well as FDA meeting requests and packages.

- Leads and actively participates in meetings with the FDA and other relevant health authorities, as necessary.

- Critically evaluates and approves reports, protocols, and documentation from various departments such as Clinical Development, Research and Development (R&D), Quality, Technical Operations, Labeling, and other relevant stakeholders.

- Represents the Regulatory Affairs department in project teams and provides regulatory advice (excluding CMC) to both internal and external clients.

- Stays updated on FDA and International Council on Harmonization (ICH) guidelines, interpreting and informing project teams about their implications in drug development.

- Establishes and manages project timelines, assessing changes to ensure submission goals and timelines are met. Builds and maintains effective working relationships with internal and external partners.

- Provides feedback and coaching to colleagues within the Regulatory Affairs Department.

- Manages, coaches, and mentors' direct reports within the department.

Prashant Tyagi

Technical Recruiter

Phone: 732-962-1575, Cell: 712-796-0595

Email: Prashant@stellentit.com

Gtalk: Prashant@stellentit.com

(link removed)