Regulatory Affairs Advisor Biosimilars

Regulatory Affairs Advisor Biosimilars

Sandoz

Holzkirchen, Germany

Job purpose:

Provide regulatory and strategic leadership to assigned biosimilar/biotech project(s) and prepare, compile and supervise independently and in due time high quality documentation for sophisticated global regulatory submissions in various countries

Your responsibilities:

  • Lead a Global Regulatory (sub)team, provide strategic input to GPT and GRS / RA team and on key HA documents and represent RA on a Global Program Team (GPT)
  • Liaison with Regulatory Authorities;
  • Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide;
  • Responsible for development and implementation of the Regulatory Strategy and Risk Documents;
  • Provide regulatory and strategic input on: development concepts and documents and clinical study protocols and protocol amendments;
  • Identify, review and prepare RA documentation and correspondence during development, registration and maintenance phase, to acquire approvals worldwide, while respecting agreed strategies and e-publishing requirements, besides assuring congruency and compliance.

Minimum requirements:

Requirements:

  • BS or MS with requisite experience and demonstrated capability. Sophisticated degree (MD, PhD, PharmD) preferred. Alternatively several years of regulatory or other meaningful proven experience;
  • At least 5 years of meaningful regulatory and drug/biologic development experience;
  • Good understanding of regulatory requirements for drug development, clinical studies, dossier filings worldwide and critical evaluation of emerging requirements, guidelines for new drugs and product life cycle maintenance;
  • Proven experience in HA negotiations in different regions;
  • Proven project leadership skills and experience in leading in matrix environment paired with proven ability to work in a complex and international setting;
  • Strong interpersonal skills and being a team player;
  • Proficient English required.

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© EuroJobsites 2020

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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