Manager, Regulatory Affairs, Advertising & Promotion

About the role

Manage US regulatory activities associated with advertising and promotion of the company’s marketed products.

Provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director.

Contribute to the advise on the development of product messages and materials across multiple functional areas.

Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.

Review US and Global (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.

Collaborate cross-functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.

Help lead and assist in all interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationships and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.

Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.

Identify process improvement for promotional review activities that would enable the establishment of portfolio-wide standardization of policies.

Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.

Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Responsibilities

• Manage US regulatory activities associated with advertising and promotion of the company’s marketed products.
• Provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director.
• Contribute to the advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Review US and Global (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.
• Collaborate cross-functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Help lead and assist in all interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationships and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
• Identify process improvement for promotional review activities that would enable the establishment of portfolio-wide standardization of policies.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Requirements

• A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion.
• A Bachelor's degree (BS) from an accredited college or university in Life Sciences. An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D) is preferred.
• Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion.
• Experience with pharmaceutical products required, biologics experience is a plus.
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred.
• Ability to review promotional materials and interact with FDA OPDP/APLB and support launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice.
• Experience supporting global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable.

Qualifications

• Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio-wide standardization of policies.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Skills

• Strong knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion.
• Experience with pharmaceutical products required, biologics experience is a plus.
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred.
• Ability to review promotional materials and interact with FDA OPDP/APLB and support launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice.
• Experience supporting global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable.

Benefits

Not specified.

Pay

$128,600.00 - $210,000.00 annually

Schedule

Hybrid: 4 days per week on site