Senior Specialist - Regulatory Affairs

1w1 week ago

MSD

US · Full-time · $106,200 – $167,200

About this role

The Senior Specialist is responsible for the review and approval of US promotional materials. As a member of the Review Team, collaborate with legal, medical, and commercial colleagues to ensure promotional practices align with regulatory guidelines, Company policies, and business objectives.

Under the direction of a Team Leader or Mentor, develop and implement effective strategies for FDA promotional submissions. Manage the development of correspondence with FDA and interpret advisory comments. Conduct regulatory risk analysis and identify regulatory issues.

Maintain current awareness of FDA advisory correspondence, evolving regulations, guidance documents, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry. Communicate basic regulatory positions in written and verbal formats. Work collaboratively across functions to support efficient promotional review practices.

Contribute to departmental or cross-functional initiatives for effective promotional review. Demonstrate strong interpersonal skills, attention to detail, and ability to manage multiple priorities simultaneously. Support quality and compliance in all regulatory activities.

Requirements

B.A. or B.S. degree with emphasis in science, health care or related fields
Minimum two years’ experience in pharmaceutical/biologics industry, preferably in regulatory, scientific, medical, legal or marketing disciplines
Basic understanding of FDA regulations relating to advertising and promotion for prescription products
Fundamental understanding of pharmaceutical industry drug development process, including labeling development
Understanding of promotional content development and review processes
Strong verbal and written communication skills
Attention to detail and ability to manage multiple priorities simultaneously
Strong interpersonal skills with strategic and analytical thinking

Responsibilities

Review and approve US promotional materials
Collaborate with legal, medical, and commercial colleagues to ensure consistency with regulatory guidelines and Company policies
Develop and implement strategies for FDA promotional submissions
Manage development of correspondence with FDA and interpret advisory comments
Conduct regulatory risk analysis and identify regulatory issues
Maintain awareness of FDA regulations, guidance documents, enforcement letters, and policy issues
Communicate basic regulatory positions verbally and in writing
Contribute to departmental or cross-functional initiatives for effective promotional review practices