Associate Director, Regulatory Affairs Advertising and Promotion

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Full Time Management US

30+ days ago Requisition

Salary Range: $ To $ Annually

Job Title:

Associate Director, Regulatory Affairs
-Advertising and Promotional Review

Department:

Regulatory

Location:

Reports To:

Senior Director, Regulatory Affairs

FLSA Status:

Exempt

Date Prepared:

POSITION SUMMARY - Delcath is seeking for a well-rounded FDA regulatory professional with experience or familiarity with promotional and medical material review for approved prescription drugs and/or devices. The position will serve on the company’s promotional/medical material review committee for both the United States and Europe for an approved drug/device in the United States and a Class III medical device in Europe.

The position will also be required to support other regulatory projects as required, including those relating to clinical trials, early-stage discovery, investigational applications, manufacturing, and quality issues.

ESSENTIAL DUTIES AND RESPONSIBILITIES
include the following. Other duties may be assigned.

Review of promotional and medical material for an approved drug in the United States and a Class III medical device in Europe.

• Management of US and Global regulatory activities associated with advertising and promotion for company marketed products.
• Provide review of US and Global product and disease state materials/communications to support corporate goals and comply with applicable laws, regulations, and guidance.
• Contribute to and advise on the development of product messages and materials across multiple functional areas, including clinical trial materials.
• Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Help lead and assist in interactions with the FDA Office of Prescription drug Promotion (OPDP), responsible for helping to maintain good working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters.
• Responsible for compliance with promotional material submissions to FDA on Form 2253
• Monitors the evolving regulatory landscape and requirements, and maintain vigilance regarding FDA promotional enforcement activities to, in partnership with management, provide stakeholders with updates and impact of enforcement activities.
• Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies.
• Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.
• Support regulatory affairs department in other tasks as needed.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• A BS or MS degree in physical or life sciences required.
• Must have at least 5 years drug with Regulatory Advertising and Promotion.
• Must have knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion
• Experience with pharmaceutical products required, drug/device combination product…