Interim VP, Regulatory Affairs

propharmagroup; United States; Hybrid; USD 100,000 - 150,000; Part time

Job summary

ProPharma Group is seeking an Interim VP, Regulatory Affairs in Berkeley Heights, NJ. This part‑time consultant will set regulatory priorities across development programs, guide FDA interactions, and oversee cross‑functional regulatory decisions during a period of limited capacity.

The role emphasizes strategic guidance, hands‑on support, and collaboration with teams to ensure timely regulatory milestones over a 4‑month engagement, with hybrid onsite work and limited travel.

Qualifications

• Senior regulatory leadership experience preferred.
• Expertise in FDA interactions and submissions.
• Ability to advise cross‑functional teams on regulatory decisions.

Responsibilities

• Set regulatory priorities across development programs.
• Lead preparation for FDA interactions and key submissions.
• Provide oversight to keep work moving during limited team capacity.
• Advise on regulatory decisions across programs.

Skills

Regulatory strategy

FDA submissions

Cross-functional leadership

Regulatory affairs

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise‑build‑operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end‑to‑end suite of fully customizable consulting solutions that de‑risk and accelerate our partners' most high‑profile drug and device programs.

Interim VP, Regulatory Affairs

Interim VP-level Regulatory Affairs consultant to provide senior strategic and hands‑on support. The consultant will help set regulatory priorities across development programs, lead preparation for FDA interactions and key submissions, advise cross‑functional teams on regulatory decisions, and provide oversight to keep work moving during a period of limited team capacity.

• 20 hours per week
• Hybrid Schedule (onsite work in Berkeley Heights, NJ)
• Minimal travel
• 4 months in duration

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.