Regulatory Affairs Manager

Regulatory Affairs Manager

Sandoz

Rotkreuz, Switzerland

Job Description

Your responsibilities include, but not limited to:

  • Assist in the preparation and management of clinical and regulatory study-essential documents, including protocols;
  • Preparation of the regulatory strategy for submissions;
  • Obtain a number of marketing authorizations in accordance with the target per year;;
  • Drive product maintenance to ensure regulatory compliance and provide support to the product launch work stream;
  • Strategic business partner to Business Development, Quality Assurance, Supply Chain as well as for other Global Regulatory Groups (RCCs);
  • Follow trends in the regulatory environment and legislation;
  • Assure awareness and alignment within the department, in order to meet requirements on time.

Minimum requirements

  • Pharmacist or natural scientist preferably with medical background;
  • German (proficient), English, French (desirable) and Italian (an asset);
  • Intermediate to senior level (at least 2-3 years Regulatory experience); experience in Biosimilars of Advantage.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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