Director Regulatory Labeling

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including ophthalmology, hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

The Director Regulatory Labeling will be running the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World labeling. We expect them to provide labeling expertise to the department and matrix environment typically carrying out responsibilities independently. We see the Associate Director owning the labeling strategies and is responsible for the management of marketed or pipeline products, across the lifecycle.

In this role, a typical day might include the following:

• Leads the Labeling Working Group and handle labeling for CCDS, USPI, EU SmPC, and RoW labeling. Handle sophisticated programs independently.
• Manages programs of highest complexity independently. Responsible for oversight and coordination of labeling strategies across program-specific deliverables and junior labeling team members.
• Leads development of target labeling documents to support the design and analysis plan for clinical trials.
• Anticipates Health Authority (HA) perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk. Communicates consequences to product portfolio.
• Prepares submission-ready labeling documents. Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate.
• Monitors worldwide regulation changes pertaining to Labeling regulations and maintains the labeling SOP and work instructions. May be responsible for leading or supplying to various continuous improvement projects.

• Bachelor’s degree (BS) from an accredited college or university in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D, MD or DO) preferred in the field of medicine or science.
• 8+ years of related Biotech or Pharma industry experience, 6or more of which are working with labeling is preferred.
• In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process. Familiar with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies.
• Expert knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines.
• Ability to handle multiple projects and prioritize work independently.
• Ability to operate in ambiguous situations and provide functional guidance to others.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.