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Senior Regulatory Affairs Officer

Date: Feb 11, 2019

Location: Harlow, GB, CM20 2FB

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

Do you have experience in European Regulatory Affairs? Would you like to work in the varied and fast-paced environment of generic products? If so, we're looking for someone like you...  

Teva is recruiting a Senior Regulatory Affairs Officer to work within the European Regulatory Affairs Team, based at our office in Harlow, Essex.  You will work in a large team of regulatory affairs professionals, working in a key hub of Teva’s Regulatory Affairs organisation. Almost 200 people, across multiple functions, are based in Harlow, working collaboratively for Teva, one of the biggest pharmaceutical companies in the UK and among the top 15 pharmaceutical companies in the world.

The focus of the role will be on the submission of new generic Marketing Authorisation Applications (MAAs) for a wide variety of products and dosage forms for retail use, registered via the Decentralised or Mutual Recognition Procedures. This high profile role will mean you working with third party partners, portfolio, local business units and a whole host of other stakeholders.   Due to the varied nature of the role, there will be the opportunity for exposure to a wide range of regulatory issues and procedures. 

Key responsibilities:

  • Review the technical content of third party dossiers against current regulatory requirements
  • Work closely with third party partners in order to prepare and submit high quality regulatory dossiers including initial Marketing Authorisation Applications, response to Health Authority questions and critical pre-launch post-approval variations
  • Be able to understand complex issues and clearly communicate issues to customer base 
  • Represent team during strategic and technical discussions, including participating in project teams
  • Enjoy the challenge of working under pressure whilst ensuring that internal and external deadlines are met

If you have significant EU Regulatory Affairs experience and would like to work in a fast paced and dynamic environment, then we’d love to hear from you!

Qualifications

  • Degree (or equivalent) in Pharmacy/Chemistry or Life Sciences related subject
  • Significant industry experience within Regulatory Affairs including practical experience of submitting and running European MAA procedures
  • A good understanding of European regulatory requirements and guidelines for generic products
  • Understanding of the scientific content of the dossier. Previous experience of working in a CMC role, or reviewing the technical content of dossiers, would be an advantage.
  • Previous supervisory or mentoring experience may be an advantage

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.