Senior Regulatory Advertising & Promotions Lead

Tris Pharma, Inc; South Brunswick (NJ); Hybride; USD 160 000 - 230 000; Plein temps

Avantages offerts par ce poste

Bonus eligible

Medical insurance

Dental insurance

Vision insurance

Rx insurance

401K with match

Life insurance

Paid Holidays

PTO

Paid Volunteer Time

Employee Resource Groups

Résumé du poste

Tris Pharma, Inc. in New Jersey is seeking an Associate Director or Director of Advertising & Promotions to join the Regulatory Affairs team.

The role provides senior regulatory oversight for review and approval of promotional materials, ensuring FDA labeling compliance and alignment with company policy. Reporting to the Head of Regulatory Affairs Advertising and Promotion, the incumbent will lead complex promotional reviews, advise on substantiation for claims, manage FDA submission

Qualifications

• Associate Director - 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 REQUIRED
• -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 REQUIRED
• Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 4 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED
• -OR-
• Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 8 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED
• FOR ALL LEVELS: 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

Responsabilités

• 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

Connaissances

FDA regulations

OPDP experience

Influence without authority

Regulatory review

Formation

PhD/PharmD

Bachelor's degree

Description du poste

Tris Pharma, Inc. in New Jersey is seeking an Associate Director or Director of Advertising & Promotions to join the Regulatory Affairs team.

The role provides senior regulatory oversight for review and approval of promotional materials, ensuring FDA labeling compliance and alignment with company policy. Reporting to the Head of Regulatory Affairs Advertising and Promotion, the incumbent will lead complex promotional reviews, advise on substantiation for claims, manage FDA submission