Senior Director, Regulatory Affairs

MSD Malaysia; North Wales (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Job summary

MSD Malaysia is seeking a Senior Director to lead a team of promotional regulatory professionals responsible for the U.S. advertising and promotion review of assigned products. The role shapes regulatory strategy across therapeutic areas, aligning with FDA regulations and company policies.

This position requires strategic leadership, risk assessment, and close collaboration with commercial, legal, and medical teams to ensure compliant messaging and effective product positioning.

Qualifications

• Experience leading regulatory review teams for promotional materials.
• Strong knowledge of FDA advertising and promotion regulations.
• Strategic thinking and cross-functional collaboration with commercial, legal and medical teams.
• Ability to manage escalations and provide regulatory risk assessments.

Responsibilities

• Lead a team of promotional regulatory reviewers (senior specialists, associate directors, and directors).
• Develop regulatory strategy across multiple therapeutic franchises for pipeline and in-line products.
• Partner with commercial and other stakeholders to align promotional strategy with regulations.
• Provide guidance on labeling input and promotional messaging in clinical trial design and labeling.

Job description

Job Description

The Senior Director manages a team of promotional regulatory professionals in the regulatory review of U.S. promotional materials for assigned products. Summary of Responsibilities: Leads a team of promotional regulatory reviewers (senior specialists, associate directors, and individual contributor directors) to provide regulatory strategy across multiple therapeutic franchises for pipeline and in-line products that competently positions our company's products, consistent with applicable FDA regulations and company policies for US advertising and promotion. Ensures strategy is aligned with overall corporate strategy and organizational goals. The senior director will be responsible for providing a regulatory risk assessment and managing escalations with senior leaders. Partners with commercial and other stakeholders to develop a promotional regulatory strategy and product positioning that aligns commercial strategy with regulations. Drives optimal regulatory strategy, planning and delivery for advertising and promotion to support the overall business goals for therapeutic area(s) of focus. Serves as critical leadership point of contact for assigned brands and associated escalations, as needed. Serves as critical partner with HH, Legal and Medical on cross-divisional transformation work inclusive of process redesign and technology enablement. Oversees direct report’s product assignments and ensures collaboration and a cohesive and integrated regulatory strategy from early development through approval and marketing. Provides guidance and coaching to direct reports on their input to product labeling, global regulatory team strategy, adequate support of promotional messaging and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion. Ensures direct reports are compliant with corporate policies and complete all required corporate and compliance training. Demonstrated ability to impact and drive regulatory decisions with senior company leadership and with FDA. Helps shape regulatory policy with OPDP and APLB on emerging topics and innovative technologies. Serves on external promotional regulatory planning committees and contributes to our company's regulatory leadership by presenting at leading external regulatory meetings (DIA, FDLI, RAPS etc.). Identifies the need for development, refinement, and implementation of department and corporate strategic initiatives that drive effective, compliant promotional regulatory review. Analyzes business needs and capacity and contributes to staffing discussions with Executive Director. Serves as a liaison with OPDP and/or APLB Team Leaders or reviewers for business-critical initiatives. Effectively interprets and communicates FDA perspectives to relevant company stakeholders and recommends policy and/or process changes as needed.