Associate Director, Advertising & Promotion Regulatory Affairs (Hybrid)

Job Description

Reports to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)

The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.

Serve as the liaison and manages correspondence with FDA’s promotional review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment 

Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk 

Provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs

Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives.

Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.

Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders

Serves as a mentor within the department.  Ability to take on more complex projects and provide promotional regulatory training and coaching to team members

Contributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review

Required Experience and Skills:

• Minimum of five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years of direct experience as the primary reviewer of advertising and promotional materials 

• Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products

• Proactive with strong cross-functional collaboration skills

• Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch

• Understanding of the product development and labeling process

• Excellent verbal and written communication skills

• Attention to detail and ability to manage multiple priorities simultaneously.

• Strong interpersonal skills with ability to demonstrate strategic and analytical thinking

• Demonstrated ability to negotiate and influence others effectively

Minimum education required:

• Minimum Requirement:  B.A. or B.S. degree with an emphasis in science, health care or related fields.

• Preferred: Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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