Director, Regulatory Advertising, Promotion, and Labeling

Overview

Director, Regulatory Advertising & Promotion (Part-time Contract)

Location:

Remote. Duration: 18-month contract, part-time. Pay Rate: $115 9/hour.

The Director, Regulatory Advertising & Promotion provides senior-level regulatory guidance for promotional activities supporting prescription products across development and commercialization stages. This role partners with cross-functional stakeholders to ensure promotional communications are compliant with FDA regulations, aligned with approved labeling, and supported by appropriate scientific and clinical evidence. The position requires independent decision-making, strong regulatory judgment, and the ability to support compliant communication strategies within a dynamic, fast-paced environment.

• Serve as the Regulatory representative on cross-functional promotional review teams
• Provide strategic regulatory guidance on promotional strategy, claim development, labeling alignment, and risk management
• Act as a regulatory advisor to Commercial and Medical stakeholders, enabling compliant use of clinical and scientific data
• Independently review and approve promotional materials in accordance with FDA regulations, product labeling, and internal standards
• Evaluate labeling changes and ensure timely, compliant updates to promotional materials
• Support promotion of products in development, including considerations related to accelerated approval and post-marketing requirements
• Serve as regulatory point of contact for interactions with FDA promotional review groups
• Lead preparation and submission of promotional regulatory filings, including advisory comments, time-of-first-use submissions, and Form 2253s
• Monitor FDA enforcement actions, regulatory trends, and evolving guidance; translate findings into internal recommendations and training
• Partner with Medical Affairs, Clinical Development, Labeling, Legal, Safety, Market Access, and Commercial teams to ensure consistent and accurate messaging
• Provide regulatory labeling guidance and support development and maintenance of product labeling documents, including Prescribing Information and patient-facing materials
• Ensure alignment between labeling content, clinical data, risk management activities, and promotional communications

• Bachelor e2 a0s degree in a scientific, healthcare, business, or legal discipline
• Advanced degree or JD preferred; equivalent experience considered
• 8+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry
• 5+ years of direct experience in Regulatory Advertising & Promotion
• Experience supporting product launches and ongoing lifecycle management
• Strong knowledge of FDA advertising and promotion regulations and OPDP submission processes
• Understanding of FDA evidence standards for promotional claims and clinical data interpretation
• Excellent written and verbal communication skills with strong regulatory judgment
• Experience with regulatory and document management systems (e.g., Veeva) and Microsoft Office tools
• Prior participation in labeling working groups and support of U.S. labeling strategies

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh e2 a0s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh e2 a0s extensive talent community that will provide you with access to Yoh e2 a0s vast network of opportunities and gain access to this exclusive opportunity available to you.

Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note:

Any pay ranges displayed are estimations. Actual pay is determined by…