Senior Regulatory Affairs Manager, CMC

Senior Regulatory Affairs Manager, CMC

Genmab

Copenhagen, Denmark

The Role

The project portfolio at Genmab is evolving and we are therefore looking for a Senior Regulatory CMC Manager to join the Regulatory Affairs team in Copenhagen.

As a Senior Regulatory CMC Manager at Genmab, you will be responsible for operational and strategic regulatory input on CMC matters to support worldwide development and commercialization. You will be part of a RA CMC team of 4 people and a RA team of 14 people.

Responsibilities

  • Develop and execute sound and robust global regulatory CMC strategies for biologic drug products at early stage development;
  • In collaboration with the RA team, provide direction and guidance to the project development team;
  • Evaluate and communicate regulatory risks and challenges;
  • Prepare and manage the regulatory CMC documentation of clinical applications (IND and IMPD), health authority briefing packages, and responses to information requests;
  • Update and maintain the CMC documentation submitted to health authorities to ensure compliance;
  • Provide advice and guidance on EU, US and selected WW regulatory legislation for CMC topics;
  • Liaise with authorities for CMC regulatory topics and represent Genmab at meetings and interactions with health authorities;
  • Collaborate with cross functional peers to facilitate and optimize product development;
  • Stay abreast with newly issued regulatory laws and guidance.

Requirements

  • Master’s degree in science, Pharmacy, Engineering or equivalent;
  • Minimum 5 years’ experience within the RA CMC area and a good understanding of compliance and biologics;
  • A track record in moving therapeutic products through various stages of development;
  • Good communication skills in English (written and oral).

Moreover, you meet the following personal requirements:

  • As a person you thrive being challenged and working in cross functional teams;
  • You have a quality mindset and are able to prioritize your work in a fast paced and changing environment;
  • You have good interpersonal and communication skills.

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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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