Job Summary: The Associate Director, Regulatory Affairs will be responsible for coordinating and completing regulatory review and approval of all commercial materials, representing the Regulatory team on both the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.
In addition, this position oversees all regulatory operational management of commercial materials (Veeva Vault, electronic document management system, applicable processes and SOPs) and will prepare all required promotional material submissions to regulatory authorities and coordinate those submissions with the regulatory operations team.
Additional key job duties and responsibilities are as detailed below and will include:
- Providing strategic advice on advertising and promotional activities for assigned products in accordance with business goals and objectives,
- Maintaining current knowledge and understanding of FDA regulations/guidelines PhRMA guidelines and company policy and sharing new developments with impacted team members,.
- Informs teams for assigned products and projects on implementation of compliant product labeling and communications.
- This position requires an ability to understand and evaluate competing perspectives and provide clear risk-based regulatory guidance based on internal and external guidelines.
- Contribute to the regulatory review of all labeling, and support regulatory strategy team during label negotiations to evaluate the impact of revisions on commercial and marketing strategy.
Principal Responsibilities: - Review, approve, and provide regulatory oversight for product labeling, advertising, promotional materials, and other commercial communications to ensure compliance with applicable FDA regulations, CFR requirements, company policies, industry standards, and other relevant regulatory requirements.
- Lead and manage promotional review processes and associated operational systems, including Veeva Vault PromoMats, electronic document management systems, workflows, SOPs, and governance processes supporting the review and approval of commercial materials.
- Prepare, compile, and coordinate required regulatory submissions for promotional materials, including FDA Form 2253 submissions, in collaboration with Regulatory Operations.
- Develop and implement regulatory labeling and promotion strategies for new, existing, and modified products, ensuring alignment between approved labeling, promotional messaging, and business objectives.
- Review and approve labeling, promotional claims, and marketing content to ensure scientific accuracy, claim substantiation, fair balance, appropriate risk communication, and consistency with approved prescribing information and regulatory commitments.
- Support the development, maintenance, and implementation of product labeling, claims support documentation, and regulatory records, ensuring materials remain current with approved indications, safety information, regulatory changes, and business needs.
- Assess evolving regulations, guidance documents, enforcement actions, and industry trends and provide recommendations regarding their impact on labeling, advertising, promotion, and commercial practices.
- Develop and document regulatory positions, risk assessments, and compliance recommendations that support sound business decisions while maintaining regulatory compliance.
- Serve as the primary regulatory liaison for advertising and promotion matters with FDA Office of Prescription Drug Promotion (OPDP) and other regulatory authorities, including management of agency interactions, responses, and meetings as appropriate.
- Participate in FDA meetings, labeling negotiations, and cross-functional product team discussions to support development of commercially viable labeling and promotional strategies.
- Apply regulatory and therapeutic area expertise to advise brand, medical, legal, and commercial teams on complex promotional, labeling, and compliance issues.
- Ensure promotional materials remain aligned with current approved labeling by assessing the impact of prescribing information updates and implementing required changes to promotional content.
- Monitor the competitive and regulatory promotional environment, including OPDP warning and untitled letters, regulatory guidance, industry activities, scientific congresses, and relevant professional forums.
- Provide training and education to internal stakeholders, contractors, and external partners regarding advertising and promotion regulations, company policies, review processes, and compliance expectations.
- Promote a culture of regulatory compliance while balancing business objectives and appropriately managing regulatory risk.
Duties and responsibilities are not limited to those listed above and may include additional assignments as required to support the objectives of the Regulatory Affairs function and the organization.
Education and Experience Qualifications: - Bachelor's degree with a minimum of 12 years of experience, Master's degree with a minimum of 8 years of experience, or PhD with a minimum of 5 years of experience in Regulatory Affairs, Labeling, Advertising & Promotion, or a closely related discipline within the pharmaceutical, biotechnology, or medical device industry.
- Thorough knowledge of regulations
- Able to interpret regulations / guidelines / standards and make appropriate judgments on what requirements are applicable to products
- Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors and translate that complexity into clear recommendations and solutions
- Ability to adapt to a quickly changing environment.
- Ability to effectively communicate issues and ideas with peers and with management.
- Ability to organize and lead meetings with cross functional teams.
- Demonstrated interpersonal, written, and oral communication skills.
- Ability to build effective working relationships throughout the organization.
- Effective communicator.
Pay Range: $148,000 - $222,000 per hour
