Associate Director, Regulatory Affairs Advertising & Promotions
About the role
The Associate Director, Advertising & Promotions at Tris Pharma, Inc. will provide senior regulatory oversight for the review and approval of promotional materials and related external communications for products. Reporting to the Head, Regulatory Affairs Advertising and Promotion, this role ensures materials are accurate, balanced, substantiated, consistent with FDA approved labeling and compliant with applicable FDA regulations, guidance, industry standards and company policies.
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
- Serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely manner to meet company goals
Requirements
- Bachelor's 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
- In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling
- Direct experience interacting with FDA OPDP
- Ability to influence without direct authority
Special knowledge or skills needed and/or licenses or certificates required
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
Work Arrangements
We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office.
Pay
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.
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.