Associate Director, Regulatory Affairs

About the Role

The Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) leads the regulatory review, strategy, and approval of promotional and non-promotional communications for assigned marketed and development products. They serve on the Promotion and Advertising Review Committees (PARC) and Medical Legal Regulatory (MLR) Review Committees, provide expert guidance on OPDP requirements and enforcement trends, and partner cross-functionally with Commercial, Medical, Legal, and other functions to ensure compliance and support business objectives.

Responsibilities

• Serve as the regulatory reviewer for promotional and educational materials, including HCP-directed, DTC, payer-focused, and internal training materials.
• Chair PARC review meetings, providing regulatory judgment on claims substantiation, fair balance, indication accuracy, safety information, and consistency with approved labeling.
• Work with Medical Affairs on promotional/non-promotional distinctions and appropriate use of clinical data.
• Collaborate with Legal and Compliance on false advertising, competitive challenges, and enforcement matters.
• Make regulatory approval decisions within delegated authority and escalate contentious matters to senior leadership.
• Develop and maintain review standards, templates, and precedent documentation.
• Partner with launch planning teams on promotional strategy for pipeline products, including pre-approval communication and initial 2253 submission strategy.
• Track and communicate emerging regulatory issues, including OPDP enforcement trends and industry updates.
• Oversee Form FDA 2253 submissions and serve as a regulatory contact for FDA OPDP correspondence.
• Contribute to company-wide promotional review policies, SOPs, and standards.
• Monitor industry associations and regulatory developments affecting promotional practice.
• Conduct internal training programs on regulatory requirements for promotional activities.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or related field (advanced degree preferred).
• 4+ years of pharmaceutical/biotechnology regulatory affairs experience, with 2+ years in Advertising and Promotion regulatory review.
• Experience across multiple promotional channels (HCP, DTC, digital, payer communications) preferred.
• Prior direct interaction with FDA OPDP a plus.

Skills

• Substantive knowledge of FDA regulations, OPDP guidance, and enforcement patterns.
• Familiarity with clinical trial design, statistical interpretation, and pharmacology.
• Strong analytical judgment and ability to distinguish regulatory risk.
• Demonstrated ability to convey regulatory guidance while maintaining relationships.
• Working knowledge of promotional review technology platforms (e.g., Veeva Vault PromoMats) preferred.

Pay

The annual starting salary for this position is between $139,920 – $174,900. Factors affecting salary include geography, skills, education, experience, and qualifications.

Benefits

Teva offers generous annual leave, reward plans, flexible schedules, tailored health support, community giveback opportunities, and career development through the Twist platform.