Regulatory Affairs Associate I

2 days ago

India Teva Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity

Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities.  The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate

How you'll spend your day
  • Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
  • Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
  • Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
  • Collaborate with scientific personnel for planning, preparation and publishing
  • Maintain working knowledge of internal and external publishing standards.
  • Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
  • Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator
Your experience and qualifications
  • B. Pharm/M. Pharm/ Master of Life Sciences.
  • Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
  • Command over spoken and written English
  • Sensitivity to the cultural diversity of a global organization
  • Good understanding of regulatory IT systems
Reports To

Manager – Regulatory Submission Management

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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