Senior Program Director, Commercial Regulatory Affairs

Senior Program Director, Commercial Regulatory Affairs

Join a dynamic and innovative organization at the forefront of global healthcare as our Senior Program Director, Commercial Regulatory Affairs. In this pivotal role, you will lead complex regulatory review committees, shape strategic regulatory initiatives, and serve as a key liaison with the FDA, ensuring our products meet the highest standards of compliance and excellence. If you’re a seasoned regulatory leader with a passion for influencing industry standards and driving impactful product launches, this opportunity offers a chance to make a meaningful difference in patients’ lives worldwide.

What You’ll Bring to the Table:

• Extensive regulatory expertise within the biopharmaceutical or healthcare industry
• Proven track record leading high-stakes, cross-functional teams and programs
• Deep understanding of FDA regulations, advertising, and promotional review processes
• Exceptional strategic thinking and decision-making abilities
• Strong influencing, negotiation, and communication skills to articulate complex ideas clearly
• Ability to manage multiple priorities and deliver impactful results under tight deadlines

Nice to Have Skills:

• Experience in regulatory advertising and promotion, including FDA communications
• Background in legal, compliance, or policy roles within pharma or biotech
• Familiarity with combination product review processes
• Past involvement in product launches or departmental strategic initiatives
• Skills in stakeholder engagement and change management

Preferred Education and Experience:

• Bachelor’s degree in Life Sciences, Law, Public Policy, Business, or related field; advanced degrees such as JD, MBA, PharmD, MS, PhD preferred
• Minimum of 7 years’ experience in regulatory affairs, legal, compliance, or related disciplines in the biopharma industry
• At least 4 years managing large, cross-functional projects with significant organizational impact
• In-depth industry knowledge, including legal and regulatory frameworks impacting healthcare compliance

Other Requirements:

• Ability to travel approximately 10% as needed
• Demonstrated ethics and alignment with organizational values
• Commitment to continuous learning and staying current on industry trends and regulatory changes

Elevate your career by leading transformative regulatory programs in a company committed to scientific excellence and ethical innovation. If you’re ready to influence global healthcare regulations and drive strategic initiatives, we encourage you to apply and become a vital part of our visionary team.