Associate Director, Regulatory Affairs – Promo Strategy (Hybrid)

Merck & Co.; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision benefits

401(k) retirement plan

Job summary

Merck & Co. is seeking a Regulatory Affairs professional to serve as the liaison with FDA promotional review divisions (OPDP/APLB) and manage complex regulatory questions and submissions for advisory comment.

The role involves proposing compliant regulatory strategies that meet business objectives while minimizing regulatory risk. You will support US marketing strategy and promotional programs, providing regulatory guidance to commercial teams and ensuring promotional materials comply with US

Qualifications

• BA/BS degree with emphasis in science, health care or related fields.
• Master’s, PhD or PharmD preferred with emphasis in science/healthcare or related fields.
• Minimum of five years in pharmaceutical/biologics industry with regulatory or scientific emphasis.
• Minimum of two years direct experience as primary regulatory reviewer of advertising and promotional materials.
• Knowledge of FDA regulations relating to advertising and promotion for prescription products.
• Strong cross-functional collaboration and interpersonal skills.

Responsibilities

• Serve as liaison with FDA promotional review divisions OPDP/APLB and manage complex regulatory questions and submissions.
• Propose compliant regulatory strategies for promotional concepts meeting business objectives.
• Provide regulatory consultation in US marketing strategy and promotional programs.
• Support US commercial teams with regulatory guidance on marketing strategies and promotion tactics.
• Participate in labeling and global regulatory team meetings to align promotional messages with study results and labeling.
• Maintain awareness of FDA advisory correspondence and evolving regulations; articulate regulatory rationale clearly.
• Mentor teammates with training on promotional regulatory review and strategy development.
• Contribute to departmental strategic initiatives to drive effective, compliant promotional regulatory review.

Skills

FDA Regulations

Regulatory Strategy

Promotion Compliance

Cross-Functional Collaboration

Negotiation

Strategic Thinking

Stakeholder Management

US Regulatory Affairs

Clinical Trials

eCTD

Regulatory Submissions

Education

BA/BS in science/healthcare

Master’s/PhD/ PharmD preferred

Tools

-

Job description

Merck & Co. is seeking a Regulatory Affairs professional to serve as the liaison with FDA promotional review divisions (OPDP/APLB) and manage complex regulatory questions and submissions for advisory comment.

The role involves proposing compliant regulatory strategies that meet business objectives while minimizing regulatory risk. You will support US marketing strategy and promotional programs, providing regulatory guidance to commercial teams and ensuring promotional materials comply with US