Executive Director, Regulatory Advertising, Promotion & Labeling

About the Company

Innovative biopharmaceutical company

Industry
Pharmaceuticals

Type
Public Company

Founded
2018

Employees
51-200

Funding
$200 million

Categories

• Pharmaceuticals
• Biotechnology
• Health Care
• Medicine
• Manufacturing
• Chemical Products

About the Role

The Company is seeking a Senior/Executive Director for Regulatory Advertising, Promotion & Labeling. This key role involves the strategic development and management of global ad, promotional, and labeling submissions, particularly with a focus on oncology. The successful candidate will be responsible for ensuring that all promotional materials meet regulatory standards, are accurate, and are supported by valid evidence. They will also be pivotal in the initial development and life-cycle management of product labeling, as well as in building and implementing systems to support compliance with FDA regulations. The position requires a minimum of 10 years of regulatory ad, promo, and labeling experience, with a preference for those with a background in oncology.Applicants for this role at The Company should hold a BA/BS degree in a health or life science-related field and have a strong understanding of ad, promo, and labeling regulations, as well as OPDP expectations. The ideal candidate will have a proven track record in regulatory affairs, including NDA/BLA/MAA, and be adept at leading submissions and serving as a liaison with regulatory authorities. Advanced knowledge of the pharmaceutical development process, excellent communication skills, and the ability to work with cross-functional teams are essential. The role demands a self-motivated individual with a strong ability to problem-solve, a high level of emotional intelligence, and a commitment to fostering a collaborative and engaged work environment.

Hiring Manager Title
Chief Regulatory Officer

Travel Percent
Less than 10%

Functions

• CEO/President
• Non-Profit Management
• Marketing
• Strategy
• General Management
• Operations