US Regulatory Strategy Director – Promo Compliance (Hybrid)

Merck; North Wales (Montgomery County); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision insurance

Job summary

Merck is seeking an Associate Director to lead the review and approval of US promotional materials, serving as the regulatory expert across legal, medical, and commercial teams. This role supports the US marketing strategy and promotional programs while ensuring compliance with FDA regulations.

The position is hybrid, with onsite three days per week in Upper Gwynedd, PA or Rahway, NJ. A strong regulatory background in pharma, excellent communication, and cross-functional collaboration are

Qualifications

• Bachelor's degree in science, health care or related fields.
• Master’s, PhD or PharmD degree preferred.
• Minimum of five years of pharmaceutical/biologics industry experience with emphasis in regulatory or scientific disciplines.
• Minimum of two years of direct experience as the primary regulatory 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.

Responsibilities

• Review and approve US promotional materials in line with regulatory guidelines and company policies.
• Liaise with FDA’s OPDP/APLB on complex regulatory questions and submissions.
• Propose compliant regulatory strategies for promotional concepts meeting business objectives.
• Provide regulatory guidance to US marketing and promotional programs.
• Participate in labeling and global regulatory meetings to align promotional messages with trial results and labeling.

Skills

FDA Regulations

Promotional Review

Regulatory Strategies

Regulatory Submissions

US Regulatory Affairs

Cross-Functional Teamwork

Negotiation

Data Analysis

Strategic Thinking

Stakeholder Management

Regulatory Compliance

Pharmaceutical Industry

Education

Bachelor’s degree in science/healthcare or related field

Master’s degree, PhD or PharmD preferred

Job description

Merck is seeking an Associate Director to lead the review and approval of US promotional materials, serving as the regulatory expert across legal, medical, and commercial teams. This role supports the US marketing strategy and promotional programs while ensuring compliance with FDA regulations.

The position is hybrid, with onsite three days per week in Upper Gwynedd, PA or Rahway, NJ. A strong regulatory background in pharma, excellent communication, and cross-functional collaboration are