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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
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. Assist in the creation or revision of the labeling SOP or work instructions.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
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, and independently. (80%)
Participates in the product development team for early development product to provide labeling leadership in developing target labeling concept to guide the design and analysis plan for clinical trials. (5%)
Mentors the junior staff members in labeling project and process management to build labeling expertise. (5%)
Prepares the submission ready labeling documents including the SPL and packaging artworks. Maintains and tracks labeling documents in the labeling repository and electronic system as appropriate. (5%)
Monitor the worldwide regulation changes pertaining to Labeling regulations and maintain the labeling SOP and work instructions. (5%)
Advanced degree (Masters, Pharm D, Ph.D, MD or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements
Associate Director 10+ years of Biotech or Pharma industry experience, 6 or more of which are in regulatory labeling, and some management experience, Sr. Manager 7+ years of Biotech or Pharma industry experience, 4 or more of which are in regulatory labeling.
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.
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 work independently and use judgment to make decisions and escalate problems appropriately. 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.
The level will be decided based on the candidate's experience and qualifications
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: 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 will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Associated topics: administrative assistant, administrative coordinator, assistant, asso, chief operations officer, facilities, front office, operation, operational assistant, staff
Associated topics: administrative coordinator, administrative officer, administrative support, associate, beverage, facilities, front desk, food, operation, records management