Global Promotional Regulatory Lead

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

Job summary

Precigen, Inc. is seeking a Sr Manager, Global Promotional Regulatory Affairs in Germantown, MD. The role leads regulatory guidance for promotional materials and labeling, ensuring compliance with FDA requirements while supporting business goals.

Ideal candidates bring 5+ years in regulatory affairs focused on promotional materials or labeling, and a strong understanding of FDA regulations. This position is full-time and on-site in Germantown, MD.

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 regulatory guidance for promotional materials and labeling.
• Manage review and approval for product promotional materials and labeling.
• Collaborate with cross-functional teams to ensure regulatory compliance and timely approvals.
• Monitor regulatory trends and communicate implications to internal stakeholders.
• Represent regulatory affairs in discussions with Healthcare Authorities as needed.

Skills

Regulatory affairs

Promotional materials

FDA regulations

Cross-functional collaboration

Labeling

Education

Bachelor's degree

Job description

Precigen, Inc. is seeking a Sr Manager, Global Promotional Regulatory Affairs in Germantown, MD. The role leads regulatory guidance for promotional materials and labeling, ensuring compliance with FDA requirements while supporting business goals.

Ideal candidates bring 5+ years in regulatory affairs focused on promotional materials or labeling, and a strong understanding of FDA regulations. This position is full-time and on-site in Germantown, MD.