Director, Advertising, Promotional & Labeling
Director, Advertising, Promotional & Labeling
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Job Description
Job Title: Director Advertising Promotional & Labeling
Reports To: Sr. VP Regulatory Affairs
Job Summary:
We are seeking a highly experienced and strategic Director of Advertising Promotional & Labeling to lead regulatory review of promotional and labeling materials for both prescription and over-the-counter (dietary supplement) products in our growing biotech portfolio. This individual will chair/participate in the Medical Legal and Regulatory (MLR) Review Committee ensure compliance with FDA regulations and partner closely with Commercial Legal and Medical Affairs to drive compliant and impactful product communication strategies.
This individual will provide guidance to the internal team and key stakeholders on the appropriate review/sign off based on the materials purpose (e.g. disease state awareness non-branded vs branded investigational vs commercial vs over-the-counter products) and will also provide guidance on the appropriate use of social media in compliance with FDAs expectations and current regulatory landscape.
The Director of Advertising Promotional & Labeling will additionally be responsible for the development and maintenance of product labeling for all products in our portfolio. This includes primary/secondary packaging US prescribing information Patient Prescribing Information Instructions for Use Supplement Facts and Core Data Sheets.
Key Responsibilities:
Serve as the regulatory lead for MLR overseeing review approval and appropriate triaging of promotional advertising and disease awareness materials directed to healthcare professionals patients consumers and clinicians.
Interpret and apply FDA regulations (including OPDP guidance) and industry best practices for product promotion and labeling.
Collaborate cross-functionally with Commercial Medical Affairs Legal and Compliance to align content with strategic messaging while mitigating regulatory risk.
Provide regulatory guidance on labeling development and maintenance including the primary/secondary packaging US Prescribing Information Patient Prescribing Information Instructions for Use (IFU) Supplement Facts and Core Data Sheet. Ensure compliance with FDA labeling requirements.
Lead interactions with FDA regarding promotional submissions advisory comments and enforcement trends.
Monitor evolving regulatory landscape guidance documents and enforcement actions; translate into actionable insights for internal teams.
Develop and deliver internal training to ensure stakeholder awareness of applicable promotional requirements.
Support regulatory strategy for new product launches and lifecycle management across promotional platforms.
Lead and mentor junior regulatory team members as applicable.
Qualifications:
Bachelors degree in life sciences pharmacy or related field required; advanced degree (PharmD PhD JD or MBA) preferred.
10 years of experience in Regulatory Affairs including a minimum of 5 years in Advertising & Promotion review (MLR/PRC environment).
In-depth knowledge of FDA regulations and OPDP standards for advertising and promotion of pharmaceuticals and over-the-counter (dietary supplements) products.
In-depth knowledge of FDA labeling requirements.
Proven experience as an MLR Chair or equivalent promotional review lead.
Experience preparing submissions to OPDP.
Excellent verbal and written communication skills with strong attention to detail.
Demonstrated ability to lead cross-functional teams and manage multiple priorities in a dynamic environment.
Preferred Experience:
Experience with 505(b)(2) allergy/immunology disease space rare disease or CNS promotional strategies.
Experience with VEEVA PromoMats system.
Experience with FDA interactions.
Familiarity with international promotional and labeling requirements a plus.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities duties and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestives employment process final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education. Expected Base salary range: $180000 $230000 USD
Required Experience:
Director
Employment Type
Full-Time
