Global Promotional Regulatory Leader

Regulatory Jobs; Germantown (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Regulatory Jobs in Germantown, MD, seeks a Senior Manager, Global Promotional Regulatory Affairs to lead regulatory guidance for promotional and labeling activities across products. The role partners with internal teams to ensure compliance with FDA requirements while aligning with business objectives.

The ideal candidate has 5+ years in regulatory affairs, strong FDA knowledge, and proven ability to drive cross-functional collaboration and strategic regulatory initiatives.

Qualifications

• Bachelor's degree in life sciences or relevant field.
• 5+ years of experience in regulatory affairs in promotional materials, global labeling or related discipline.
• Strong understanding of FDA regulations and guidelines.

Responsibilities

• Lead promotional material and labeling strategy for assigned products and therapeutic areas.
• Provide regulatory guidance and manage review/approval for promotional materials and labeling.
• Lead label working groups and promotional review meetings with cross-functional teams.
• Ensure submissions comply with internal policies and regulatory guidance.
• Support interactions with Healthcare Authorities related to label negotiations and promotions.
• Monitor evolving regulations and communicate implications to stakeholders.
• Other duties as assigned.

Skills

Regulatory leadership

FDA regulations

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in life sciences or relevant field

Job description

Regulatory Jobs in Germantown, MD, seeks a Senior Manager, Global Promotional Regulatory Affairs to lead regulatory guidance for promotional and labeling activities across products. The role partners with internal teams to ensure compliance with FDA requirements while aligning with business objectives.

The ideal candidate has 5+ years in regulatory affairs, strong FDA knowledge, and proven ability to drive cross-functional collaboration and strategic regulatory initiatives.