Senior Manager, Regulatory Labelling

Location
Tarrytown, NY, United States
Posted
Oct 12, 2020
Ref
19739BR
Required Education
Masters Degree/MBA
Position Type
Full time
Lead 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.
In this role, a typical day might include the following:
  • Owns 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%)
  • We expect you to stay up to date with the worldwide regulation changes pertaining to Labeling regulations and maintain the labeling SOP and work instructions. (5%)
This role might be for you if:
  • Advanced degree (Masters, Pharm D, Ph.D, MD or DO) preferred in the field of medicine or science. Regulatory experience can offset 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 coordinate 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 call out 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. education requirements.
  • Associate Director 10+ years of Biotech or Pharma proven experience, 6 or more of which are in regulatory labeling, and some management experience, Sr. Manager 7+ years of Biotech or Pharma experience, 4 or more of which are in regulatory labeling.
  • We expect you to have In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process.

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.
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