Job Title : Head of Regulatory Affairs -- this is an FTE role with a generous base salary, bonus, and RSUs

Location : near Bridgewater, NJ - hybrid - 3 days in office

Position Summary

We are seeking an experienced and dynamic Head of Regulatory Affairs to lead our regulatory submissions and overall strategy. The Head of Regulatory Affairs will manage the regulatory team and work closely with R&D, Technical Operations, Clinical Development, and external consultants. The successful candidate will guide the strategic direction of our development programs, ensuring they meet U.S. and global regulatory approval standards.

This role is critical to advancing our product portfolio, achieving commercial success, and maintaining strong relationships with regulatory agencies such as the FDA and EMA.

Key Responsibilities

• Strategic Leadership : Develop and implement regulatory strategies for pipeline projects to ensure timely regulatory approvals with optimal labeling. Lead IND/NDA filings and oversee post-approval obligations.
• Team Management : Build, lead, and inspire the Regulatory Affairs team. Recruit and retain top talent, creating a high-performance culture.
• Regulatory Submissions : Oversee all regulatory submissions, including 505(b)(1), 505(b)(2), and 505(j) filings. Ensure compliance with U.S. and global regulatory authorities.
• Agency Liaison : Serve as the primary point of contact for global regulatory agencies, including the FDA and EMA. Lead regulatory interactions, submissions, and negotiations.

Qualifications

• Experience : Minimum of 10-15 years of experience in regulatory affairs within the pharmaceutical or biopharmaceutical industry, with a strong track record of leadership and regulatory submissions.
• Regulatory Expertise : Experience with FDA regulatory pathways, including 505(b)(1), 505(b)(2), and 505(j). Significant experience leading successful IND, NDA, and MAA filings.

Education

• A higher degree such as a PhD, PharmD, or MD in a relevant scientific discipline (pharmacy, chemistry, biology, or related fields) is required.