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Regulatory Affairs Job at Teva Pharmaceuticals

Teva pharmaceuticals has released a regulatory affairs job for science graduates. Candidates from Bsc, MSc, B.pharma , M.pharma may apply for this post. Find the complete details below.

Function: Regulatory Affairs
Sub Function: Medical Regulatory Affairs
Job Location: Mumbai, Maharashtra

Qualifications

Msc /M.Pharm /BSc /B.Pharm with a Scientific or Regulatory background or equivalent combination of education and experience

Company Profile

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 centred 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

  • Develop 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.
  • Work within 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.
  • Work in a team environment with moderate supervision.
  • Performs all other job related duties as required by management.

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