Senior Manager, Labeling - new job in Remote, US

Job Title: Senior Manager, Pharmaceutical Labeling and Promotion
Location: Remote
Job Type: Permanent Full-Time

We are searching for a permanent full-time Senior Manager, Pharmaceutical Labeling and Promotion who will be an expert on FDA regulations, guidance, and enforcement actions governing prescription drug promotion, and who will be responsible for the Regulatory review and approval of both US promotional and medical materials.

As part of this role, the successful candidate will:

• Provide expert regulatory advice to promotional and medical teams that is consistent with FDA regulations and guidance, PhRMA guidelines, and company standards.
• Work collaboratively with the Legal, Medical, and Commercial members of the review teams to ensure material optimizes the product profile while being consistent with applicable regulatory guidelines and company policies and procedures.
• Demonstrate an understanding of labeling of assigned product(s), as well as competitive products.
• Assess the impact of labeling changes on promotional material.
• Serve as the primary product contact for communications with the Office of Prescription Drug Promotion.
• Maintain in-depth knowledge and understanding of regulatory environment related to advertising and promotional and scientific exchange.
• Ensure the impact of new information related to advertising and promotion of prescription drugs and scientific exchange is communicated appropriately within the organization.

Minimum Qualifications:

• Must have 3-5 years of experience as the Regulatory reviewer for prescription drug promotional materials and experience in pharmaceutical/biological regulatory

• Undergraduate degree in a biological or healthcare scientific discipline

• Knowledge of regulations, guidance, and FDA enforcement actions related to advertising and promotion of prescription drugs

• Strong preference for candidates who have experience with successful interactions with the Office of Prescription Drugs or the Advertising and Promotional Labeling Branch, and who have an understanding of pharmaceutical product and labeling development

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.