Senior Regulatory Strategist, Advertising & Promotion (work from home)

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

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 (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
• Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements)
• Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy
• Demonstrate the ability to 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, offering solutions-oriented recommendations
• Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes
• Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders
• Mentor junior team members and contribute to building 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

Preferred Qualifications

• Experience supporting product launches or high-visibility brands
• Familiarity with global regulatory considerations
• Prior experience leading or facilitating MLR/PRC committees

Benefits

• Opportunity to operate as a strategic, enterprise-level regulatory leader
• High visibility across commercial and medical leadership teams
• Ability to directly influence brand strategy while ensuring compliance and patient safety
• Flexible work arrangements with remote work options
• Challenging assignments, diverse product types, and exposure to various therapeutic areas
• Mentorship from experienced regulatory professionals
• Supportive and inclusive team environment

Employee Insights

• Patient-led in everything we do: We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.
• Supportive and inclusive environment: We thrive on collaboration, caring, and inclusivity—enabling our people to work together to solve complex problems and share knowledge.
• Opportunities for career growth: We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, offering ample opportunities for learning and growth.
• Flexible work arrangements: We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while contributing to a supportive team environment.
• Diverse and global client exposure: We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies.
• Learn from experts: You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills.