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Sr Officer, Regulatory Affairs

Date: Mar 19, 2021

Location: Beijing, 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

Job Summary: Responsible for the operation of Regulatory Affairs Activities of Teva Generic / new product portfolio of Respiratory and Regulatory system operation, including GI system coordinating and training, regulatory submission and maintenance activities, to ensure timely submissions / approval of responsible products and delivery of regulatory intelligence.

Major Accountabilities:

  • Assistant on all regulatory activities of development compounds (registration) and marketed products (life cycle management) in Respiratory TA.
  • Responsible for new product and Gx registration, product license renewal, variation and clinical trial application, including prepares registration dossiers correctly and timely.
  • Prepare product labeling correctly and timely
  • Prepare and compile regulatory dossiers for submission and ensure submission projects are on track and filed in a timely manner.
  • Support China operations on relevant legislation, directives and regulations within China including Gx and Specialty business in responsible TAs
  • Work closely with internal partners to ensure compliance with internal process and external regulatory requirements
  • Responsible for the related Regulatory system and database coordination and training e.g. GI

Qualifications

  • At least University Degree in life science, medicine, pharmacy or material science.
  • At least 1 years’ experience of regulatory affairs in the pharmaceutical industry
  • Basic knowledge of regulatory and healthcare system in China.
  • Strong English communication skills both written and oral in view of building effective stakeholder relationship
  • Excellent interpersonal skills , teamwork and collaboration
  • Innovative and creative, openness to change and ability to think out of box.
  • Results oriented, entrepreneurial and self-motivating.

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.