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Regulatory Affairs Project Manager

Date: Apr 5, 2021

Location: Tel Aviv, IL, 1111

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

 

Project  management of all Gx new submissions for defined markets.

Works on a variety of generic products for a certain defined area, Strategy preparation, tracking projects, reviewing and resolving issues, acting as a main point of contact for affiliates and regional supporting functions.

 

  • RA delegate within project teams and assuring execution of optimal regional/local affiliates regulatory submission strategies.
  • Strategic and operational regulatory support to affiliates in the defined area.
  • Close collaboration with stakeholders globally, in the region and in-country including regulatory affairs, R&D, portfolio, supply chain and commercial.
  • Manages, coordinates and consolidates files suitability & feasibility for portfolio's wish lists and files due-diligence reports; gaps analysis and mitigation plans for strategy PRC in alignment with COREX centers teams.
  • Discuss with R&D projects in development prior to project allocation, ensuring that the regulatory activities are set and are in line with market requirements; i.e. attendance and active participation in selection meetings, introduce RA strategy input in PLM, and provision of FSD and submission timelines.
  • Proactive Project management of submissions execution according to submissions WP, tracking progress and interact with the regulatory staff affiliates as needed. Provide support to local affiliates by opening bottle necks to ensure on-time submission and launches.
  • Takes responsibility from strategy definition until launch and act as the RA delegate for regional functions forums including R&D and Portfolio.
  • Have an overview of the entire projects registration status for a defined area until launch.
  • Internally works in interface with RA officers in the RA centers and with regional maintenance & compliance manager.

Qualifications

  • Minimum 5 years’ experience in Regulatory Affairs or R&D, preferably with experience in a similar role.
  • Degree in life sciences/ pharmacy or equivalent qualification(s)/experience
  • Excellent team-work and communication skills
  • Ability to think and act strategically
  • Drive for results and excellence
  • Proven project management skills and attention to details
  • Good knowledge of the industry
  • Confidence and communication skills are important for managing relationships both internally and externally

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Director, Gx New submissions, International Markets RA

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.