Senior Regulatory Strategist, Advertising & Promotion
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Job Description
Senior Regulatory Strategist guiding FDA advertising and promotion compliance at Parexel, a global clinical research organization. Advising commercial, medical, legal, and clinical stakeholders on regulatory strategy.
Responsibilities:
- Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
- Act as a trusted subject matter expert in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
- Independently review and approve promotional and non-promotional materials for compliance with FDA regulations, guidance, and industry standards
- Interpret and apply FDA guidance, identifying risks and opportunities to inform regulatory strategy
- Pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
- Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy
- Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
- Lead discussions on risk assessment and mitigation strategies
- Support or lead regulatory review committees such as PRC/MLR
- Stay current with regulatory trends, FDA warning letters, and industry best practices, sharing insights with stakeholders
- Mentor junior team members and contribute to organizational regulatory capability
Requirements:
- 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
- Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
- Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
- Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
- Demonstrated ability to independently review promotional materials and make sound regulatory decisions
- Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
- Excellent communication, influence, and stakeholder management skills
- Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset
- Experience supporting product launches or high-visibility brands
- Familiarity with global regulatory considerations (nice to have)
- Prior experience leading or facilitating MLR/PRC committees
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