Senior Regulatory Strategist, Advertising & Promotion

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a key regulatory partner to the Medical Affairs, Legal, Commercial, Marketing, and Clinical teams.

• Serve as a subject matter expert in FDA regulations related to Advertising & Promotion.

• Offer high-level guidance on intricate regulatory situations.

• Review and approve both promotional and non-promotional materials for compliance with regulations independently.

• Analyze and apply FDA guidance to pinpoint risks and opportunities.

• Modify regulatory strategies in response to changing FDA expectations, enforcement trends, and business requirements.

• Contribute strategic insights on messaging, claims, and communication strategies during development phases.

• Collaborate with Legal and Medical Affairs to ensure communications are balanced, compliant, and scientifically accurate.

• Facilitate discussions on risk assessment and mitigation.

• Support or lead committees focused on regulatory reviews.

• Keep abreast of regulatory trends, FDA enforcement actions, and industry best practices.

• Mentor junior team members and enhance the organization’s regulatory expertise.

⛳️ Requirements

• At least 7 years of experience in Regulatory Affairs in the pharmaceutical, biotech, or medical device sectors, particularly with a focus on Advertising & Promotion.

• In-depth knowledge of FDA regulations, guidance documents, and enforcement trends pertaining to promotional activities.

• Proven track record as a strategic advisor and trusted partner to senior stakeholders.

• Extensive collaboration experience with Medical Affairs, Legal, and Commercial teams.

• Demonstrated capability to independently review promotional materials and make informed regulatory decisions.

• Strong experience in interpreting and applying FDA guidance to practical scenarios, with the ability to adjust strategies as necessary.

• Excellent communication, influence, and stakeholder management abilities.

• Strong critical thinking and problem-solving skills, with a proactive and solution-oriented approach.

• Experience in supporting product launches or managing high-visibility brands is preferred.

• Familiarity with global regulatory considerations is a plus.

• Prior experience in leading or facilitating regulatory review committees is preferred.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Paid time off.

• Life insurance.

• Additional benefit offerings in alignment with applicable plans.

• Potential eligibility for extra incentives, bonuses, or other compensation programs.