Regulatory Advertising & Promotions Associate Director

Dennis Partners; United States; Hybrid; USD 180,000 - 200,000; Full time

Benefits offered by this job

Annual target bonus

Equity

Comprehensive benefits

Flexible working arrangements

Job summary

An established industry player is seeking a Regulatory Advertising & Promotions Associate Director to join their innovative team. This role involves providing strategic regulatory support for promotional materials, ensuring compliance with FDA regulations, and leading cross-functional discussions. With a focus on collaboration and patient-centered culture, this position offers a unique opportunity to impact the development of novel therapeutics. The company, known for its strong cash position and approved products, provides a hybrid work environment, making it an exciting time to contribute to their mission in the biotechnology sector.

Qualifications

• 7+ years in Pharma/Biotech with 4+ years in Regulatory Advertising & Promotions.
• Experience with FDA regulations and promotional review processes.

Responsibilities

• Review promotional materials for compliance with regulations and internal policies.
• Lead discussions in review committees and collaborate with cross-functional teams.
• Manage interactions with the Office of Prescription Drug Promotion.

Skills

Regulatory Compliance

Attention to Detail

Commercial Regulatory Strategy

Project Management

Communication Skills

Negotiation Skills

Problem Solving

Education

Bachelor's Degree

Advanced Degree (MS, PhD, or PharmD)

Tools

Veeva Promomats

Job description

Regulatory Advertising & Promotions Associate Director

6 days ago Be among the first 25 applicants

This range is provided by Dennis Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$180,000.00/yr - $200,000.00/yr

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 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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Strategy/Planning and Other

Industries

Biotechnology Research and Pharmaceutical Manufacturing