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Regulatory Affairs Specialist

Date: May 16, 2019

Location: Jakarta, ID, 13710

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

The purposed of this job is to Prepare regulatory documents for the new products for export and product transfer which are required by the current local Authority regulations, company standard, corporate policy, and QEHS procedures

What will you do:

  1. Prepare required documents  for the purpose of regulations/registration, key documents for registration, patent and trademark if needed for New products for Export/ Product Transfer, including e renewals and variations applications for existing products for Export/ Product Transfer
  2. Compile data/documents and provide application of existing products for renewal and variation submissions
  3. Maintain and update product dossier in order to ensure the documentation are in line with QC and Production documentation in the plant/ source.
  4. Communication and following up the required documents to the dossier source from MS&T, QC/QA in PT Actavis Indonesia, RA Actavis group or the Third Party
  5. Follow up the artwork process of new product and artwork change of existing product
  6. EHS compliance

Qualifications

To eligible for this position you need to:

1.Have a University Degree majoring pharmaceutical (pharmacist)
2.Fresh Graduate are welcome to apply
3.Fluent in English
4.Familiar with common software products
5.Exposed to computer literate (MS Office)

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

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.