US Promo Regulatory Lead - Hybrid

MSD; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Job summary

MSD in Rahway, NJ is seeking an Associate Director to oversee the review and approval of US promotional materials, serving as the regulatory expert to ensure compliance with FDA regulations and company policies. The role involves collaboration with legal, medical, and commercial teams to support marketing objectives.

This hybrid position requires onsite work three days per week in Upper Gwynedd, PA or Rahway, NJ, and includes interaction with FDA divisions OPDP/APLB, regulatory strategy

Qualifications

• B.A. or B.S. degree with an emphasis in science, health care or related fields.
• Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields
• Minimum of five years of pharmaceutical/biologics industry or related experience with an 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 all US promotional materials and act as regulatory expert coordinating with legal, medical and commercial colleagues
• Propose compliant regulatory strategies and solutions for promotional concepts that meet business objectives
• Provide regulatory consultation in development and implementation of US marketing strategy and promotional programs
• Support US commercial teams by providing regulatory guidance on marketing strategies and promotion tactics
• Participate in labeling and global regulatory team meetings to align promotional messages with labeling and product results
• Maintain current awareness of FDA advisory letters and enforcement actions affecting US promotion
• Provide regulatory training and coaching to team members
• Contribute to departmental strategic initiatives to drive compliant promotional review

Skills

Cross-functional collaboration

Verbal communication

Written communication

Attention to detail

Interpersonal skills

Strategic thinking

Negotiation and influence

Education

B.A./B.S. degree in science/healthcare

Master’s/PhD/PharmD in science/healthcare

Job description

MSD in Rahway, NJ is seeking an Associate Director to oversee the review and approval of US promotional materials, serving as the regulatory expert to ensure compliance with FDA regulations and company policies. The role involves collaboration with legal, medical, and commercial teams to support marketing objectives.

This hybrid position requires onsite work three days per week in Upper Gwynedd, PA or Rahway, NJ, and includes interaction with FDA divisions OPDP/APLB, regulatory strategy