(Associate) Director, Regulatory Affairs, Advertising & Promotions

Proclinical; New Jersey; Hybrid; USD 130.000 - 190.000; Vollzeit

Zusammenfassung

Proclinical Staffing seeks an (Associate) Director, Regulatory Affairs, Advertising & Promotions for a hybrid role in New Jersey. You will oversee the regulatory review of promotional materials to ensure accuracy, balance and FDA compliance, and provide strategic regulatory input across the company.

You will lead complex promotional reviews, manage FDA submission requirements, and maintain up-to-date knowledge of FDA guidance and enforcement actions.

Qualifikationen

• PhD/PharmD with 3+ years as a regulatory reviewer of promotional materials.
• Bachelor's with 7+ years as a reviewer of promo materials in pharma/biotech.
• Experience reviewing advertising and promotional materials under FDA rules.

Aufgaben

• Review and approve advertising and promotional materials for FDA compliance.
• Provide strategic regulatory advice for compliant yet competitive promos.
• Be a key regulatory resource for promotional initiatives across the company.

Ausbildung

PhD or PharmD in life sciences, pharmacy, medicine or related discipline

Bachelor's degree in life sciences, pharmacy, medicine or related discipline

Jobbeschreibung

(Associate) Director, Regulatory Affairs, Advertising & Promotions – Permanent – New Jersey

Proclinical is seeking an (Associate) Director, Regulatory Affairs, Advertising & Promotions for an exciting and growing CNS-focused pharmaceutical company based in New Jersey.

Primary Responsibilities:

In this role, you will provide senior regulatory oversight for the review and approval of promotional materials and related external communications for products. You will help ensure materials are accurate, balanced, substantiated, consistent with Food and Drug Administration (FDA) approved labeling and compliant with applicable FDA regulations, guidance, industry standards and company policies. You will support compliant business execution by providing strategic regulatory advice, leading complex promotional reviews, managing FDA submission requirements and improving review processes.

The position is hybrid in New Jersey, requiring 3 days per week onsite.

Skills & Requirements:

• PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry OR
• Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 7 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry

The (Associate) Director, Regulatory Affairs, Advertising & Promotions will:

• Review and approve advertising and promotional materials ensuring compliance with applicable FDA laws, regulations and guidance documents
• Provide strategic input and clear regulatory advice towards the development of compliant yet competitive advertising and promotional material
• Key resource for regulatory advice on promotional and advertising initiatives throughout the company
• Maintain continued awareness and understanding of new and existing FDA regulations, guidance documents and enforcement actions regarding advertising and promotion of pharmaceutical products and communicates these to PRC and senior management, as needed
• Provide training regarding FDA expectations on advertising and promotion, as requested
• Provide strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of product portfolio
• Prepare and approve Form FDA-2253 submissions to OPDP

Proclinical Staffing is an equal opportunity employer.