Labeling Regulatory Affairs Manager: FDA Compliance

Supernus Pharmaceuticals; Rockville (MD); On-site; USD 110,000 - 135,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Stock equity awards

Paid time off

Life insurance

Job summary

Supernus Pharmaceuticals is seeking a Manager of Regulatory Affairs Labeling to lead the development, review, and approval of commercial product labeling and printed component artwork. You will collaborate with Clinical Development, Medical Affairs, Quality, and Packaging vendors to ensure labeling compliance with FDA and ICH guidelines.

The role requires expertise in labeling content governance, change control, and cross-functional leadership.

Qualifications

• Pharm.D. or advanced degree with regulatory affairs experience.
• Experience creating labeling and managing artwork/governance.
• Strong knowledge of FDA labeling regulations and ICH guidelines.

Responsibilities

• Develop, review, and approve Prescribing Information, Patient Information, and Medication Guides in line with FDA regulations.
• Lead cross-functional labeling and artwork initiatives across departments.
• Respond to FDA inquiries and support post-marketing labeling commitments.
• Draft and revise CCDS and participate in TPP/Labeling to support lifecycle.
• Coordinate SPL file development and ESG submissions.
• Mentor and train junior staff on labeling requirements and SOPs.

Skills

Regulatory affairs

Labeling governance

Cross-functional collaboration

Project management

Education

Pharm.D.

Master's (Regulatory Affairs)

Bachelor's (related field)

Tools

Veeva Vault RIM

Veeva PromoMats

Job description

Supernus Pharmaceuticals is seeking a Manager of Regulatory Affairs Labeling to lead the development, review, and approval of commercial product labeling and printed component artwork. You will collaborate with Clinical Development, Medical Affairs, Quality, and Packaging vendors to ensure labeling compliance with FDA and ICH guidelines.

The role requires expertise in labeling content governance, change control, and cross-functional leadership.