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Regulatory Affairs manager, MEA region

Date: Jul 22, 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

Position Summary
The Market RA manager is responsible for new submissions, product maintenance and life cycle management in different GCC markets and Africa
Market RA is key contributor to the development, execution and management of the regulatory strategy.
The individual is expected to be an expert of the local regulations and should be able to function independently in the daily management of projects including the preparation/review of related key documents (M1-5).
The manger works closely with other functional areas such as commercial, supply chain, QA, pharmacovigilance and will be the RA focal point for site RA, Global RA and local agents working in this area

Tasks and Responsibilities

  • Support submissions of new product applications in Africa & GCC markets 
  • Ensure the maintenance and update of registrations in accordance with the relevant legislation, regulations and guidelines
  • RA expert, and such be able to identify opportunities and risks
  • Create project management plans to ensure supply to markets  
  • Ensure approval of new product submissions and amendments
  • Be the RA focal point for communication with the distributors and regulatory agents 
  • Review and approval of artwork and printed packaging
  • Establish and maintain effective relationships with all stakeholders
  • Adjust and Establish company SOP’s.
  • Responsible for High level DD of relevant dossiers
  • Well understanding of the business environment

Qualifications

  • B.Pharm degree and related work experience.
  • Minimum 5 years regulatory affairs experience
  • Experience with CTD files, and well understanding of the different modules mainly CMC part
  • Good team player and communication skills
  • Self-motivated and proactive
  • Good Project management
  • Able to handle multiple projects simultaneously
  • Must speak fluent English and be a proficient scientific writer
  • Written and spoken Arabic is advantage
  • Experience in writing SOP’s and implementing SOP’s would be advantageous

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Sin. Director, International Markets Regulatory Affairs

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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.