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Regulatory Affairs Specialist / Regulatory Affairs Senior Specialist

Date: Jun 9, 2021

Location: Istanbul, TR, 34055

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!

The Role

  • Managing the process of both local and import marketing authorization submissions with preparing files and executing submission, following up and finalizing all related processes.
  • Fulfilling the responsibilities of the license holder in regards to registered products with preparing and executing submissions, following up and finalizing all related processes.

Main Responsibilities

  • Ensuring the translation of the files provided from global departments (GMP audit, registration submissions or variation submissions), evaluating, preparing and filing submissions to the Authority.
  • Submitting the application within the specified period by obtaining all the additional documents from  global departments that may be requested by the Authority or preparing locally in a format in accordance with the local regulations and following up with the correspondence.
  • Ensuring the necessary coordination and information exchange with the medical department and/or other business units during the preparation and evaluation of SmPC-PIL process with determining a common strategy.
  • Carrying out correspondence with domestic and international contacts for all registered/non-registered products and following-up the regulatory processes.
  • Meeting with the Authority or commission members to carry out and follow up the registration procedures when needed.
  • Preparing and following up submissions related to non-prescription medicine/food supplement/cosmetic product/medical device.
  • Preparing Type I and Type II variations for both registered products and products in process of registration in accordance with the regulations and guidelines, executing the submission and following up with the process.
  • Following domestic and international regulations regarding registration procedures.
  • For projects carried-out together with third parties, ensuring the necessary information transfer and carrying out the necessary internal/external work coordinately 
  • Preparing and updating local SOPs.
  • Preparing reports/tables, ensuring the registration files and records are securely archived and the databases are up to date.

Competencies

  • University Degree in pharmacy, medicine or relevant scientific (e.g. chemistry, biology) field
  • Minimum 3 years of relevant work experience
  • Excellent verbal and written communication skills in English
  • Proficient with Microsoft Office
  • Ability to respond change in positive manner
  • Ability to collaborate and influence
  • Ability to work in compliance with company policies, laws and ethical values
  • Customer-oriented attitude
  • Team player
  • Expertise in the regulatory affairs procedures
  • Ability to collect and leverage data

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.