Regulatory Affairs Manager CMC

Regulatory Affairs Manager CMC

Galderma

Uppsala, Sweden

As Regulatory Affairs Manager CMC you will represent Regulatory Affairs in development and life cycle management activities, with a focus on the CMC aspects of the product registrations. The role includes ensuring post-approval regulatory compliance and you will be accountable for assessing the regulatory impact of product/process improvements. You will be involved in scientific writing and submissions to authorities. You will act as the regulatory subject matter expert and provide guidance to projects and organization teams.

Key tasks:

  • Provide regulatory CMC guidance in R&D and Manufacturing projects, improvements, and line related activities;
  • Develop regulatory CMC strategies for marketing applications worldwide;
  • Assess the regulatory impact of product and process changes/improvements to ensure compliance;
  • Scientific writing for regulatory submissions worldwide;
  • Coordinate regulatory submissions to authorities;
  • Keep updated on changes to regulatory requirements and inform the team;
  • Contacts with regulatory bodies, affiliates, partners and consultants.

Skills & Qualifications:

  • At least a BSc in Life Sciences or Engineering;
  • Regulatory affairs experience with medical devices or pharmaceuticals, specific experience with CMC is a merit;
  • Professional level Swedish and English.

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© EuroJobsites 2022

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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