Interim VP, Regulatory Affairs

ProPharma Group; Raleigh (NC); Hybride; USD 66 125 000 - 77 146 000; Temps partiel

Résumé du poste

ProPharma Group seeks an Interim VP, Regulatory Affairs 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.

Role is 20 hours per week with a Hybrid Schedule (onsite in Berkeley Heights, NJ) and minimal travel, for a duration

Qualifications

• Senior regulatory affairs executive with VP-level experience.
• Ability to set regulatory priorities across development programs.
• Experience leading FDA interactions and submissions.

Responsabilités

• Set regulatory priorities across development programs.
• Lead preparation for FDA interactions and key submissions.
• Advise cross-functional teams on regulatory decisions.
• Provide oversight to maintain progress with limited team capacity.

Description du poste

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.