462BR Regulatory Labeling, Manager

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Amar Annamalai
Amar Annamalai's picture
462BR Regulatory Labeling, Manager

Job Summary and Essential Functions:
If you are looking for an uncommon opportunity — a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals — it’’s time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
Manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, and EU SmPC. Maintains and appropriately archives submitted and approved labeling documents and packaging component labeling. Participates in the development of the labeling objectives early in product development to assist teams in creating development strategies to achieve these objectives. Reports to the Director of Regulatory Labeling.
• Manages the development, review, approval, and maintenance of labeling for designated products. Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, with guidance by supervisor (90%)
• Prepares the submission ready labeling documents including the SPL and packaging artworks. (5%)
• Maintains and tracks labeling documents in the labeling repository and electronic system as appropriate. (5%)
Experience and Required Skills:
Job requirements:
• Good understanding of the labeling process and related issues in medical safety regulatory and/or corporate.
• Good understanding of regulatory agencies, industry practice, packaging manufacturing process, and the drug development process.
• Ability to lead Cross Functional Labeling Team (CFLT) to address labeling issues, develop plans of action, and oversee completion of labeling project.
• Familiarity with FDA, EMEA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines.
• Ability to assimilate clinical and scientific information, and present it in a concise manner.
• Ability to assess situation with regard to appropriateness of working independently versus seeking guidance from supervisor and proactively share information with peers and generate discussion to resolve complex issues.
• Ability to handle multiple projects and prioritize work independently. Attention to detail and strong word processing skill.
• At minimum, a Bachelor’s degree (BS) from an accredited college or university, five years of industry regulatory experience, three or more of which in the regulatory labeling or relevant experience
• Good understanding of regulatory agencies, industry practice, packaging manufacturing process, and the drug development process.
• Microsoft Word, PDF

We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the Internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex -www.candex.com
ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.

Deadline: Contact employer

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