Associate Director, Regulatory Affairs

Teva Pharmaceuticals; West Chester (Chester County); On-site; USD 140,000 - 175,000; Full time

Benefits offered by this job

Generous annual leave

Flexible working schedules

Career development via Twist

Job summary

Teva Pharmaceuticals in the United States seeks an Associate Director of Regulatory Affairs, Advertising and Promotion to lead regulatory review and approval of promotional materials, ensuring accuracy, balance and compliance with FDA OPDP requirements.

You will chair PARC meetings, manage Form FDA 2253 submissions, collaborate with Legal, Medical and Commercial teams, and drive strategy for pipeline launches, while supporting corporate objectives and a high standard of scientific integrity.

Qualifications

• 4 years of pharmaceutical or biotechnology regulatory affairs experience, with at least 2 years in Advertising and Promotion regulatory review.

Responsibilities

• Serve as regulatory reviewer for promotional materials across channels.
• Chair PARC review meetings and ensure substantiation, fair balance, and labeling consistency.
• Collaborate with Legal and Compliance on enforcement-related matters.
• Oversee Form FDA 2253 submissions and OPDP correspondence.
• Support PARC review and training activities and 2253 submissions.

Skills

OPDP knowledge

FDA regulatory review

Cross-functional collaboration

Education

Bachelor’s degree in life sciences, pharmacy, or related field

PharmD/MS/PhD a plus

Tools

Veeva Vault PromoMats

Job description

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 elevate 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 2253 submissions.

Governance and Continuous Improvement

• Contribute to the development and maintenance of company-wide promotional review policies, SOPs, and review standards.
• Monitor industry associations (e.g., PhRMA, DIA, RAPS Ad Promo groups) and regulatory developments affecting promotional practice.
• Conduct internal training programs for Commercial, Medical Affairs, and other stakeholders on regulatory requirements for promotional activities as needed.

Your Skills and Experience

Education and Experience

• Bachelor’s degree in life sciences, pharmacy, or related field preferred; advanced degree (PharmD, MS, PhD) a plus.
• 4 years of pharmaceutical or biotechnology regulatory affairs experience (or equivalent), with at least 2 years specifically in Advertising and Promotion regulatory review. Experience across multiple promotional channels including HCP-directed materials, DTC advertising, digital and social media, congress presence, and payer communications preferred.
• Prior direct interaction with FDA OPDP through submissions, correspondence, or advisory comment requests a plus.

Knowledge and Skills

• Substantive knowledge of FDA regulations governing pharmaceutical promotion, current OPDP guidance documents, and OPDP enforcement patterns, as well as current industry standards/practices for promotional review.
• General familiarity with clinical trial design, statistical interpretation, and pharmacology relevant to claims substantiation.
• Strong analytical judgment, including the ability to distinguish material regulatory risk from stylistic preference in promotional review.
• Demonstrated ability to clearly and persuasively convey regulatory guidance while preserving productive working relationships.
• Working knowledge of promotional review technology platforms preferred (Veeva Vault PromoMats, Zinc MAPS, or similar).

Salary Range

The annual starting salary for this position is between $139,920 – 174,900 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

How We’ll Take Care of You

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to [e-mail] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.