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Regulatory Affairs Associate II - EU Post approvals

Date: Apr 5, 2021

Location: Navi Mumbai, IN, 560052

Company: Teva Pharmaceuticals

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

  • Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
  • Responsibility for MA compliance with both legislation and business needs.
  • Prioritise, plan and monitor submission for allocated procedures while documenting and informing involved parties of progress.
  • To give regulatory support to project teams, stake holders and European Units for defined product responsibilities.
  • Support the development and implementation of regulatory strategies for defined projects.
  • Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
  • Maintain and develop awareness of current/pending regulatory legislation and guidelines.
  • Support the defined processes within the department and provide input where improvements can be made.

Function

Regulatory Affairs

Qualifications

  • M Pharm/ MSc: 6+ years of experience
  • B Pharm/BSc: 6+ years of experience

Sub Function

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.