Associate Director, Regulatory Affairs

We Are Teva We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact 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, serves on the Promotion and Advertising Review Committees (PARC) and Medical Legal Regulatory (MLR) Review Committees, provides expert guidance on OPDP requirements and enforcement trends, and partners cross-functionally with Commercial, Medical, Legal, and other functions to ensure that all product communications are scientifically accurate, balanced, truthful and non-misleading, and compliant with applicable regulations while supporting business objectives.

The role reports to the Senior Director, Regulatory Affairs and is one of a team of Ad Promo regulatory professionals supporting one or more therapeutic areas or product portfolios.

How You’ll Spend Your Day Promotional Review Serve as the regulatory reviewer for promotional and educational materials for assigned products, including HCP-directed materials (detail aids, journal advertising, congress materials, disease state education), DTC materials (television, digital, print, social media), payer-focused materials (AMCP dossiers, budget impact tools), and internal training materials.

Chair the PARC review meetings, providing regulatory judgment on claims substantiation, fair balance, indication accuracy, safety information presentation, and consistency with approved labeling, and mitigation approaches for aggressive positioning.

Work in close alignment with Medical Affairs on the promotional/non-promotional distinction, medical information and scientific exchange activities, and the appropriate use of clinical data in promotional context.

Collaborate with Legal and Compliance on false advertising, competitive challenges, and enforcement-related matters.

Make regulatory approval decisions on promotional materials within delegated authority and escalate contentious or precedent-setting matters appropriately to senior regulatory leadership.

Help develop and maintain review standards, templates, and precedent documentation to help ensure consistency across the promotional review portfolio.

Partner with the launch planning team and Regulatory Operations on promotional strategy for pipeline products approaching approval, including pre-approval communication planning, launch materials development, and initial 2253 submission strategy.

Track and communicate to your teams emerging regulatory issues including OPDP enforcement trends, industry PhRMA Code updates, guidance implementation, and competitor labeling and promotional developments.

FDA Interaction and Submissions Oversee Form FDA 2253 submissions for all promotional materials within assigned scope, ensuring timely and complete submissions consistent with FDA electronic submission requirements (eCTD via ESG).Serve as primary or supporting regulatory contact for FDA Office of Prescription Drug Promotion (OPDP) correspondence, including responses to untitled letters, warning letters, advisory comments, and information requests.

Partner with Regulatory Operations to support PARC review and training activities and…