Job Title: Head of Regulatory Affairs
Location: Bridgewater, NJ
Reports to: Chief Scientific Officer
Company Overview
We are a specialty pharmaceutical company dedicated to developing innovative and enhanced products that address unmet clinical and commercial needs of current FDA-approved molecules. Through extensive R&D and clinical efforts, we focus on improving formulations, packaging, and drug delivery methods. Our proprietary enhancements are aimed at benefiting patients and providing value to the healthcare system. We utilize the FDA’s 505(b)(2) regulatory pathway for many of our products.
Position Summary
We are seeking an experienced and dynamic Head of Regulatory Affairs to lead our regulatory submissions and overall strategy. Reporting directly to the Chief Scientific Officer, 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.
- Cross-functional Collaboration: Partner with R&D, Technical Operations, Clinical Development, and Business teams to support product development and commercialization.
- Regulatory Strategy: Drive creative and strategic regulatory pathways for product approvals. Stay ahead of regulatory trends and competitive intelligence.
- Compliance Oversight: Ensure adherence to regulatory policies, post-marketing commitments, safety reporting, and lifecycle management of products.
- Executive Leadership: Serve as a key member of the Executive Leadership Team, shaping the company’s vision and strategic direction.
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.
- Leadership: Proven ability to build, lead, and manage high-performing regulatory teams. Strong interpersonal and mentorship skills.
- FDA/EMA Relationships: Pre-established relationships with regulatory agencies
- Drug Development Knowledge: Comprehensive understanding of the drug development process, including R&D, CMC, preclinical, clinical requirements, and commercialization for sterile dosage forms.
- Strategic Thinker: Proactive, creative, and forward-thinking approach to regulatory strategy. Ability to anticipate future regulatory trends and consequences, and engage regulators in developing new approval pathways.
- Cross-functional Expertise: Experience working collaboratively with cross-functional teams (CMC, preclinical, clinical, marketing, legal) to ensure seamless product development and compliance.
- Project Management: Strong organizational and project management skills, with the ability to manage multiple complex regulatory projects simultaneously.
- Communication Skills: Outstanding written, oral, and presentation skills. Ability to present to and influence internal teams, regulatory agencies, and external stakeholders.
- Global Perspective: Broad knowledge of U.S. and global regulatory environments, with direct experience working with the FDA, EMA, and other international regulatory authorities.
Preferred Qualifications
- Demonstrated track record of successfully interacting with regulatory agencies, resulting in timely approvals of pharmaceutical products.
- Experience with post-approval lifecycle management, including safety reporting, label updates, and product modifications.
- Familiarity with regulatory processes for sterile injectable products and ophthalmic drugs.
- Ability to manage external regulatory consultancies and advisory boards when necessary.
- Experience supporting business development and due diligence efforts.
Education
- A higher degree such as a PhD, PharmD, or MD in a relevant scientific discipline (pharmacy, chemistry, biology, or related fields) is required.
