Group Leader Regulatory Affairs – US Labeling

  Regulatory Affairs

Job title: Group Leader Regulatory Affairs – US Labeling

Company: Teva Pharma

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 col

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 Hands on leader in regard to daily workload in addition to managerial responsibilities. Subject Matter Expert in the development, review, and electronic compilation of labeling documents to align with the Reference Listed Drug, company goals, and submission requirements for assigned ANDAs / 505b2s and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents as well as preparing full labeling responses to FDA via appropriate filing mode. Experience in developing labeling content that requires carve outs due to protected language associated with patent/exclusivities. Subject Matter Expert in the development of Structured Product Labeling (SPL) documents (content and data elements) to ensure alignment with associated application as well as applicable FDA regulations and guidances. Work with US Regulatory Labeling Team and Regulatory Operations 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. Guide the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool TVT. Assignment of all labeling update projects (RLD updates, safety changes, site transfers, etc.). Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling. 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 If you are a current Teva employee, please apply using the internal career site available on ‘Employee Central’. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. 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: Mumbai, Maharashtra

Job date: Sat, 02 Jul 2022 22:29:48 GMT

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