Regulatory Labeling Manager - FDA-Focused Biopharma

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

401(k) match

Life insurance

Stock equity awards

Employee stock purchase program

Wellness benefits

Job summary

Supernus Pharmaceuticals Inc is seeking a Manager of Regulatory Affairs Labeling to oversee the development, review, and approval of commercial product labeling and printed artwork across the portfolio. You will partner with Clinical Development, Medical Affairs, Commercial, Quality, and Operations to ensure labeling accuracy and regulatory compliance.

You will mentor teams on labeling requirements, manage change control, and drive content governance, including SPL, CCDS, and regulatory

Qualifications

• Pharm.D. with 1+ years of regulatory affairs experience or higher degrees with 4+ (master’s) / 5+ (bachelor’s) years.
• Experience with labeling creation, artwork governance, or related content management.
• Strong knowledge of FDA labeling regulations and ICH guidelines.

Responsibilities

• Develop, review, and approve commercial labeling and printed artwork per FDA/ICH guidelines.
• Lead cross-functional labeling and artwork initiatives across Regulatory, Clinical, Medical, and Commercial teams.
• Support FDA inquiries and post-marketing commitments; coordinate with Regulatory Operations on submissions.
• Draft and revise CCDS, TPP/TPL; coordinate SPL files for FDA submission via ESG.

Skills

Communication skills

Interpersonal skills

Presentation skills

Independent worker

Education

Pharm.D.

Master’s degree

Bachelor’s degree

Tools

Microsoft Office Suite

Veeva Vault RIM

Veeva PromoMats

Job description

Supernus Pharmaceuticals Inc is seeking a Manager of Regulatory Affairs Labeling to oversee the development, review, and approval of commercial product labeling and printed artwork across the portfolio. You will partner with Clinical Development, Medical Affairs, Commercial, Quality, and Operations to ensure labeling accuracy and regulatory compliance.

You will mentor teams on labeling requirements, manage change control, and drive content governance, including SPL, CCDS, and regulatory