Global Promotional Regulatory Lead

Precigen; Germantown (MD); Hybrid; USD 110,000 - 130,000; Full time

Job summary

Precigen is seeking a Sr Manager, Global Promotional Regulatory Affairs in Germantown, MD to lead regulatory strategies for promotional materials and labeling across products.

The role reports to the SVP, Regulatory Affairs and requires expertise in FDA regulations, cross-functional collaboration, and strong leadership to drive compliant communications and labeling aligned with business goals.

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 the promotional material and labeling strategy and activities for assigned products and therapeutic areas.
• Provide regulatory guidance and manage regulatory aspects of the review and approval for product promotional materials and labeling.
• Lead label working groups and promotional review meetings, as needed. Collaborate with cross-functional reviewers to determine next steps and approval status.
• Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies procedures as well as applicable regulatory guidance and requirements.
• Partner effectively with internal teams as needed to ensure thorough, timely and efficient review and completion of all materials.
• Provide guidance and expertise on new marketing concepts and promotions tactics for assigned products.
• Support interactions with Healthcare Authorities including discussions related to label negotiations, and promotional materials for advisory comments for full approval and accelerated approval products.
• Monitor evolving regulations, enforcement trends, guidance documents, and industry developments impacting promotional and labeling activities and communicate implication and recommendations to internal stakeholders.
• Other duties as assigned.

Skills

Regulatory leadership

FDA regulations

Cross-functional collaboration

Regulatory submissions

Attention to detail

Education

Bachelor’s degree in life sciences or relevant field

Job description

Precigen is seeking a Sr Manager, Global Promotional Regulatory Affairs in Germantown, MD to lead regulatory strategies for promotional materials and labeling across products.

The role reports to the SVP, Regulatory Affairs and requires expertise in FDA regulations, cross-functional collaboration, and strong leadership to drive compliant communications and labeling aligned with business goals.