Job Description

This company is developing and commercializing novel therapeutics for the treatment of nonalcoholic steatohepatitis (NASH) – also known as Metabolic dysfunction-associated steatohepatitis (MASH). They are seeking a Regulatory Advertising & Promotions Associate Director (or Senior Manager) to provide commercial regulatory strategy and support to the organization. Reporting into the Regulatory Advertising & Promotions Senior Director, you will be responsible for promotional review for multiple programs in the United States and serve as a member of the Promotional Review Committee. This company offers a collaborative, patient-focused culture and hybrid working arrangements. With one approved product and a strong cash position, now is an exciting time to join this rapidly growing organization!

Responsibilities:

• Review and approve the regulatory content of materials created for product promotion, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
• Represent the commercial regulatory perspective at the Promotional Review Committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal/Compliance
• Lead discussions in review committees, collaborating with stakeholders from Legal, Medical, and commercial teams to reach consensus on promotional materials.
• Serve as internal expert on FDA regulations, guidance and enforcement trends governing the promotion of company’s products.
• Assume a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.
• Manage interaction with the Office of Prescription Drug Promotion (OPDP) including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission of promotional materials under cover of FDA Form 2253.
• Ensuring stakeholder awareness on planned and approved label updates and how they impact Promotional and Medical materials. Provide key stakeholders with guidance on implementation of ISI, and labels in a timely manner.
• Align and maintain effective communication channels with Medical, Marketing, Regulatory, Legal, and corporate counterparts.
• Provide training on FDA regulations for advertising and promotion to employees and agents of the company.
• Participate in company working groups on advertising and promotion standards and guidelines.
• Assist on the development strategies of US labeling to ensure support for anticipated promotional messages and claims.
• Position reports to Senior Director, US Advertising and Promotion. In the absence of the Senior Director, the Associate Director is responsible for day-to-day operations.

Knowledge and Skills:

• Bachelors degree required. Advanced degree (MS, PhD, or PharmD) preferred.
• Seven+ years of Pharmaceutical/Biotech industry experience with four or more years in Regulatory Advertising & Promotions.
• Experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents.
• Strong attention to detail with the ability to check documents for accuracy as well as consistency.
• Experience with Subpart H and/or Subpart E submissions a plus but not required.
• Proficiency using promotional review software, such as Veeva Promomats.
• Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives.
• Knowledge of clinical study design and statistical analyses in the assessment of promotional claims.
• Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
• Ability to manage multiple projects at once. Consistently meets deadlines without compromise to work.
• Ability to distill complexity into understandable and actionable language.
• Willingness to travel to various meetings or sites, including overnight trips.
• Willing to roll up sleeves and do whatever is needed to ensure Regulatory success.
• Must be comfortable with ambiguity in a small company environment

This company has offices in the Greater Philadelphia area and in the Boston area. The Associate Director must be onsite three days a week in one of these locations.

The budgeted salary range for this position is US$180,000 to $200,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

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