Advertising, Biology, Biotech and Pharmaceutical, Business Administration, Change Management, Communication Skills, Cross-Functional, FDA (Food and Drug Administration), FDA Requirements, Functional Programming Languages, Healthcare, Industry Standards, Industry/Trade Analysis, International Health, Legal, Multitasking, Negotiation Skills, Product Reviews, Product/Service Launch, Public Policy, Regulations, Regulatory Compliance, Strategic Planning, Time Management, Willing to Travel
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 youre 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 Youll 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:
- Bachelors 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 youre ready to influence global healthcare regulations and drive strategic initiatives, we encourage you to apply and become a vital part of our visionary team.
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Apollo Professional Solutions
Apollo Professional Solutions was founded by Gayle A. Williams in 1983 as a technical staffing firm supporting New England aerospace companies. Today, Apollo has grown into a $40 million year company, with 5 regional offices nationwide that offers diversified support to industries that include: defense, military, aeronautical, civil, food & beverage, healthcare, marine, pharmaceutical and scientific industries, as well as local government. We are an equal opportunity employers, that is also certified as a Women’s Business Enterprise by WBENC as well as the State of Massachusetts (SOWMBA Office.)