Director, Regulatory Labeling Operations

Location
Tarrytown, NY, United States
Posted
Nov 12, 2020
Ref
22328BR
Required Education
Bachelors Degree
Position Type
Full time
Responsible for providing oversight to Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks for marketed products as well as products in full development. Coordinates the preparation and delivery of submission-ready labeling documents. Works with Manufacturing/Supply Chain, Regulatory Operations, and various labeling vendors (e.g., SPL, translations, QC tool, etc.). Leads or supports labeling content and/or artwork system development and implementation. Supports the creation or revision of labeling SOPs or work instructions.

In this role, a typical day might include the following:
  • Leads Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks, e.g., carton, container labeling, printed package insert, for full development products as well as marketed products.
  • Leads and/or advises Packaging Teams to ensure packaging component content and artworks are aligned with internal labeling policies, standard operating procedures and worldwide health authority regulations and guidance.
  • Leads Regulatory Operations Labeling Group and provides training and mentorship for staff.
  • Maintains relationships with internal partners such as Manufacturing/Supply Chain, Regulatory Operations, cross functional packaging team members, as well as various labeling vendors (e.g., SPL, translations, readability, QC tool)
  • Provides labeling expertise to novel packaging design initiatives
  • Leads and/or collaborates with internal SME's to develop & implement labeling content and/or artwork management system solutions
  • Supports operational labeling deliverables not limited to SPL, EMA translations/linguistic reviews, preparing submission ready labeling documents, proofreading/QC, labeling contributions to periodic reports
  • Monitors worldwide regulation changes pertaining to Labeling
  • Supports the creation or revision of labeling SOPs or work instructions
This role might be for you if:
  • Bachelor's degree (BS) from an accredited college or university, preferably in the field of Health/Science OR 10+ years of proven experience
  • In-depth knowledge of worldwide Regulatory Agencies, industry practice, packaging manufacturing process, and the drug development process. Familiarity with FDA, EMEA, and international packaging regulations and industry practices for biologic and combination product.
Experience
  • We seek 10-15+ years of Biotech or Pharma industry experience in regulatory labeling and packaging, and some management experience
  • Experience implementing new corporate labeling and/or artwork systems
  • Experience managing labeling process initiatives
  • Ability to lead/advise Cross Functional Packaging Teams to navigate printed component labeling issues, develop plans of action, and resolve complex issues.
  • Ability to work independently and use judgment to make decisions and advance problems appropriately.
  • Ability to handle multiple projects and prioritize work independently for self and direct reports.
  • Attention to detail and strong word processing and organizational skill.


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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