Senior Global Promotional Regulatory Lead

Precigen, Inc; Germantown (MD); On-site; USD 110,000 - 130,000; Full time

Job summary

Precigen, Inc in Germantown, MD is seeking a Senior Manager, Global Promotional Regulatory Affairs to provide regulatory leadership for promotional, medical, and external communications while supporting labeling development for assigned products. The role reports to the SVP, Regulatory Affairs and partners with internal teams to ensure compliant promotional and labeling activities.

The ideal candidate will have a Bachelor’s degree in life sciences and 5+ years of regulatory affairs experience in

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 internal policies and regulatory guidance.
• Partner effectively with internal teams to ensure thorough review of all materials.
• Provide guidance on new marketing concepts and promotions tactics for assigned products.
• Support interactions with Healthcare Authorities including label negotiations and promotional materials discussions.
• Monitor evolving regulations and communicate implications to internal stakeholders.

Skills

FDA regulations knowledge

Education

Bachelor’s degree in life sciences

Job description

Precigen, Inc in Germantown, MD is seeking a Senior Manager, Global Promotional Regulatory Affairs to provide regulatory leadership for promotional, medical, and external communications while supporting labeling development for assigned products. The role reports to the SVP, Regulatory Affairs and partners with internal teams to ensure compliant promotional and labeling activities.

The ideal candidate will have a Bachelor’s degree in life sciences and 5+ years of regulatory affairs experience in