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Regulatory Affairs Associate II Full-time Job

1 week ago Pharma Mumbai   13 views
Job Details
  • 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.
  • Prioritize, 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.

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Company Description
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.