(Associate) Director, Regulatory Affairs, Advertising & Promotions

(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.

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