Job title: Regulatory Affairs Associate II – 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!
- 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 development of content of labeling, side-by-side comparisons, SPL update 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 like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives etc. and any other projects as per requirement 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 minimum supervision.
- Assists the Group leader in the assignments and review of labeling documents.
- Performs all other job related duties as required by management.
- Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience
Medical Regulatory Affairs
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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.
Location: Navi Mumbai, Maharashtra
Job date: Tue, 15 Mar 2022 02:57:08 GMT
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