Manager, Regulatory Affairs Labeling

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 an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Manager of Regulatory Affairs Labeling is responsible for the development, review, and approval of commercial product labeling (Prescribing Information, Patient Information, Medication Guides, and Instructions for Use) and printed component artwork (cartons, container labels, blister foils and pouches) across the assigned Supernus commercial portfolio. This role partners with Clinical Development, Medical Affairs, Commercial, Quality, Technical Operations, Supply Chain, and external graphic and packaging vendors to ensure all labeling and artwork content is accurate and compliant with FDA regulations and ICH guidelines. The Manager serves as the subject matter expert on labeling and artwork content governance for assigned products and mentors cross-functional partners on labeling requirements, associated change controls, and content governance.

Essential Duties & Responsibilities:

• Develops, authors, and revises Prescribing Information, Patient Information, Medication Guides, Instructions for Use (IFUs) current Food and Drug Administration (FDA) regulations (21 CFR Part 201) and guidance documents.
• Leads cross-functional labeling and artwork initiatives and drives alignment between Regulatory Affairs, Clinical Development, Medical Affairs, Commercial, Quality, Technical Operations, and Supply Chain.
• Supports response to FDA labeling inquiries, Information Requests, and post-marketing commitment deliverables; partners with Regulatory Operations on submission publishing.
• Drafts and revises Company Core Data Sheets (CCDS) and participates in Target Product Profile/Labeling (TPP/TPL) to support product portfolio and lifecycle of products.
• Coordinates the development of Structured Product Labeling (SPL) files for FDA submission, including proofing, validation, and electronic submission via the FDA Electronic Submissions Gateway (ESG).
• Maintains labeling change history, source-text documentation, annotations, and supporting documents for labeling revisions.
• Reviews and approves printed-component artwork for regulatory compliance, readability, accuracy, and alignment with approved labeling content.
• Coordinates with external graphic vendors and packagers and Supply Chain to ensure timely and accurate artwork development for new launches, product line extensions, and post-approval changes.
• Authors, reviews, and improves departmental SOPs, work instructions, and best-practice documentation for labeling and artwork management.
• Manages, mentors and trains junior regulatory staff and cross-functional partners on labeling requirements, change control, artwork review standards, and content-governance SOPs.
• Performs regulatory intelligence by monitoring regulation changes and issuance of new guidance documents, as well as new product labeling from competitors and products in therapeutic areas that may impact the labeling of the Supernus portfolio.
• Supports promotional activities by assisting in incorporation of new labeling content into Important Safety Information documents and implementation of newly approved labeling content in print and digital formats.
• Educates and trains cross-functional departments on new labeling regulations and guidance documents that impact the portfolio.
• Department representative on selected project teams for commercial product launches and completion of post-marketing commitments.
• Other duties as assigned.

Supervisory Responsibilities:

• May perform supervisory responsibilities as assigned, consistent with business needs and the scope of the role.

Knowledge & Other Qualifications:

• Pharm.D. with 1+ years of experience, master's with 4+ years, or a bachelor's with 5+ years of relevant experience in Pharmaceutical Regulatory Affairs.
• At least two years of experience focused specifically on labeling creation, artwork preparation or related content-governance activities.
• Working knowledge of FDA regulations governing prescription drug labeling, including 21 CFR Part 201 and ICH guidelines.
• Experience with therapeutic areas for which Supernus promotes products.
• Experience with the Microsoft Office Suite.
• Experience with regulatory document-management or artwork-management systems (Veeva Vault RIM, Veeva PromoMats, or equivalent).
• Experience with SPL review and/or generation and drug listing.
• Requires excellent interpersonal and good corporate presentation skills.
• Excellent written and verbal communication skills.
• Excellent attention to detail and ability to support multiple projects simultaneously.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $110,000 to $135,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.