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Senior Manager Regulatory Affairs 100%

Date: Apr 25, 2019

Location: Basel, CH, 4010

Company: Teva Pharmaceuticals

Company Info

Teva Pharmaceuticals International GmbH (“TPIG”) is a subsidiary of Teva Europe based in Switzerland. The company trades mainly Global Specialty medicines & Branded Generics Products with many markets in EU and the US.

The company is also hosting the trading hub for our Latin American markets. The company is engaged in Research and Development through its R&D hub based in Basel, it is also engaged in manufacturing and sales activities which are coordinated out from its headquarter in Jona.

Business Purpose

Teva Pharmaceuticals International GmbH is looking for a Senior Manager Regulatory Affairs to obtain registration for new Specialty products in Europe and to ensure that the registrations for existing marketed Specialty products are maintained.

 

Main Responsibilities

  • Manage both centralised and decentralised submissions of Teva’s Specialty medicinal products in Europe
  • Ensure that regulatory obligations for marketing authorisations are met
  • Provide a point of contact for EMA and national European Regulatory Authorities
  • Coordinate all regulatory aspects related to Teva’s Clinical Trial Applications in Europe
  • Collaborate with internal and external teams to provide European Regulatory Advice (e.g. to Global Regulatory Affairs, GM, R&D, manufacturing, clinical, non-clinical, medical, project teams and others)
  • Participate in the development of RA strategies for new Specialty product submissions starting from early stages of pre-clinical development to life-cycle management in order to ensure “label-driven” product development
  • Provide supervision and support to other RA professionals and administrative support staff
  • Ensure compliance by performing all required RA post-approval activities
  • Provide post-approval support for existing Specialty products, including co-ordination and preparation of variations to optimize the commercial life cycle of products, development of line extensions, and preparation of license renewal applications
  • Support the development and/or subsequent maintenance of product labeling
  • Co-ordinate Scientific Advice procedures with national Regulatory Authorities and the EMA
  • Track, interpret and advise on European and national regulations to maximize and protect the effective life of products

Qualifications

  • A strong scientific background with at least a MSc degree in life sciences, ideally with a PhD
  • A minimum of 5 years substantial European RA experience – including practical experience with European regulatory procedures and interactions with regulatory authorities – preferably gained in a European based company in a Specialty Therapeutic Area
  • Experience in managing new submissions and/or maintenance work
  • Thorough knowledge of the fundamental processes and regulatory requirements in the areas of research, drug development and marketing of Specialty medicinal products
  • Scientific and technical expertise, including the ability to develop robust regulatory plans covering all phases of drug development
  • Detailed knowledge of and ability to interpret regulatory requirements for Specialty medicinal products in Europe together with the awareness of the commercial implications of pharmaceutical regulations
  • Proven ability to manage complex regulatory issues and prioritize activities
  • Project management skills
  • Analytical skills to interpret available data and make critical regulatory decisions
  • Ability to organize and manage diverse activities in a multi-disciplinary environment, communicating with global and local groups
  • Leadership and inter-personal skills for efficient cross-functional communication
  • Efficiency in problem solving as applied to regulatory issues
  • Ethical, scientific and intellectual integrity
  • Excellent verbal and written communication and presentation skills in English

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Director, Head of TA Migraine –

Specialty Regulatory Affairs Europe

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.