Associate Director, Regulatory Affairs Advertising & Promotions

Primary duties/responsibilities

• Reviews and approves advertising and promotional materials ensuring compliance with applicable FDA laws, regulations and guidance documents
• Provides 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
• Maintains 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
• Provides training regarding FDA expectations on advertising and promotion, as requested
• Provides strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of product portfolio
• Prepares and approves Form FDA-2253 submissions to OPDP
• Contributes to, and drives, Advertising and Promotion regulatory process improvements in relevant areas, as needed

Special knowledge or skills needed and/or licenses or certificates required

• Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum of 7 years’ experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED
• In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling REQUIRED
• Direct experience interacting with FDA OPDP REQUIRED
• Ability to influence without direct authority REQUIRED

Work Arrangements

We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office.

Anticipated salary range

Anticipated salary range: $180 to $225K/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits

• In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.