Parexel
Manager, Regulatory Affairs Advertising & Promotion (Work from Home)
United States - Remote
Sponsorship not specifiedDetected 22 days ago
Stakeholder ManagementBrand StrategyClinical TrialsFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingCritical ThinkingRegulatory Affairs
About the role
- From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
- Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
- We take our work personally, we do it with empathy and we're committed to making a difference.
Responsibilities
- Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations
- Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes
- Mentor junior team members and contribute to building organizational regulatory capability
- 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
Requirements
- 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
Nice to have
- Experience supporting product launches or high-visibility brands
- Familiarity with global regulatory considerations (nice to have)
- Prior experience leading or facilitating MLR/PRC committees
- Opportunity to operate as a strategic, enterprise-level regulatory leader
- Ability to directly influence brand strategy while ensuring compliance and patient safety
- What Sets This Role Apart
- Parexel is an equal opportunity employer.
Benefits
- Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
- Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
- 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
- Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
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This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.