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Regulatory Affairs Associate III

Date: Mar 25, 2021

Location: Hangzhou, CN, -

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

  1. To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements, specifically China market
  2. Support the life cycle management of APIs from RA perspective
  3. Review and approve ROS, specification and analytical control when required
  4. Coordinate DMF preparation and related activities for On Time Submissions for China market
  5. Proactively collaborates with the Regulatory Associates responsible for products (on site or new products), working as one  team
  6. Respond to deficiency letters and coordinate related activities
  7. Coordinating pre-launch activities from RA perspective
  8. Manages the regulatory aspects and related tasks of the assigned commercial APIs
  9. Evaluate change requests and address the required submission to support the requested change. Follow through the submission
  10. Maintain up to date the DMFs according to the required regulation of updating for China market.
  11. Support customers regarding Service Requests, giving relevant professional information in the shortest of time
  12. Continue learning of regulatory guidance, SOPs and work processes

Qualifications

  • High degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology
  • Experience of years in Regulatory Affairs, preferable API registration.
  • Knowledgeable in China regulatory guidelines and NMPA requirements

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

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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.