Group Leader Regulatory Affairs – US Labeling

  Regulatory Affairs

Job title: Group Leader Regulatory Affairs – US Labeling

Company: Teva Pharmaceuticals

Job description: 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!

Job Description

  • Subject Matter Expert in the development of labeling documents to ensure alignment with the Reference Listing Drug. This includes QC, proofing, editing and formatting of documents, and coordinating the review and approval of final submission documents with US Labeling Team members.
  • Create, revise, and prepare labeling documents needed for full responses to FDA via appropriate filing mode. This includes but is not limited to develpment of content of labeling, side-by-side comparisons and other required submission materials, as necessary.
  • Guide the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool TVT.
  • Work with US Regulatory Labeling Team to ensure assigned projects are submitted on-time following the eCTD requirements related to labeling.
  • Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling.
  • Assists in the training of new labeling personnel
  • Lead a team and provide support to prepare high quality Labelling submissions.
  • Performs all other job related duties as required by management.

Qualifications

Qualification

Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience

Experience

6 years (Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

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.

Expected salary:

Location: Navi Mumbai, Maharashtra

Job date: Wed, 25 May 2022 05:06:54 GMT

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