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Manager, Regulatory Affairs, Labeling/Biosimilar

Date: Jan 18, 2021

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

The Regulatory Biosimilars Labeling Manager is a tactical and strategic role within Gx Regulatory Affairs and is generally responsible for creating labeling documents in support of regulatory submissions filed as Biosimilars, 505(b)2s, and/or ANDAs, as needed, working closely with the Artwork Management Team for artwork creation, tracking labeling implementation, completing structured product labeling submissions, and creating labeling sections of routine reports as necessary. The manager will support the regulatory strategy teams in scheduling and managing internal Teva labeling committees for products falling to their area of responsibility.

 

Essential Duties and Responsibilities:

 

  • Labeling Content Development: Develops and manages the creation of labeling content (prescriber labeling, patient labeling, carton and container labeling), holds required gPWG meetings, as appropriate, for submissions (original applications, labeling supplements, Annual Reportable Changes). Creates labeling submission documents (word, pdf, and Structured Product Labeling).
  • Labeling Implementation: Manages implementation of new and revised labeling. Creates and distributes mark-up labeling documents and artwork requests, works with Artwork Management Team to create and approve artwork for labeling components, tracks implementation activities. Reviews and approves labeling components in Veeva. Maintains current and historical labeling activity history files. Maintains the US Labeling Repository SharePoint site.
  • Periodic Reporting: Completes labeling sections for periodic reporting (PADERs and Annual Reports). Supplies current labeling components for reports as needed.
  • Structured Product Labeling: Creates, updates, and submits Structured Product Labeling (SPL) content of labeling for marketed products and regulatory applications. Ensures SPL labeling content and data elements are maintained for marketed products.
  • Supports process improvements within the labeling function.
  • Follows Teva Safety, Health, and Environmental policies and procedures
Qualifications

Minimum Qualifications:

 

  • Bachelor's degree in scientific field of study such as Biology, Chemistry, or other related life science
  • 5 plus years of experience working in pharmaceutical industry with 4 plus years of experience in regulatory affairs and/or regulatory labeling with a focus in Biosimilars and 505(b)2s.
  • Biosimilars, regulatory affairs, and/or drug development experience

 

Preferred Qualifications:

  • 7 plus years of pharmaceutical industry experience with at least 5 plus years of experience in regulatory affairs with increasing level of responsibility and experience in drug product labeling, strategy, and submissions

 

Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To
In process of validation
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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


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