Director Regulatory Affairs

Director Regulatory Affairs

Affimed

Heidelberg, Germany

Responsibilities

  • Independently develop and implement regulatory submission strategies for assigned complex programs and/or portfolio of products;
  • Represent the Regulatory Affairs function in cross-functional development program teams and support/lead the teams in all regulatory matters;
  • Deputize for VP Regulatory Affairs;
  • Manage all operational aspects of the Regulatory Affairs Function (e.g. processes and timelines) while ensuring regulatory conformance;
  • Contribute to process improvement within the department through identification of improvement areas and creation/revision of new processes to fulfill improvement objectives;
  • Lead the preparation and conduct of different direct agency interactions like scientific advice meetings, deficiency meetings, phone contacts etc.;
  • Lead the interaction with national or global Competent Authorities (FDA, EMA) during product development and registration by leading the coordination of the dossier submission process and following up with responses to validation and deficiency letters;
  • Collaborate proactively with all internal and external stakeholders (CRO’s, consultants);
  • Build and maintain a sustained and trustworthy relationship with the Competent Authorities;
  • Prepare and compile the dossier in submission-ready format according to the regulatory requirements of different regions (e.g. EU, US, Canada, Japan) by involving external vendors whenever deemed necessary;
  • Keep and further develop competence in the area of regulatory affairs and provide training/supervision of junior staff whenever needed;
  • Ensure working compliance with the respective SOPs.

Requirements

  • University Degree in natural science or equivalent education, post-doctoral degree is a plus;
  • At least 6 years experience in Regulatory Affairs, in US and EU drug development and drug product maintenance;
  • Regulatory competence certifications are a plus;
  • Experience in cell/gene therapy products is a plus;
  • Very good understanding of the regulatory requirements and guidelines for filings worldwide and critical evaluation of emerging requirements and guidelines for new drugs;
  • Demonstrated ability to work independently on multiple projects in parallel;
  • Fluent in oral and written English, additional German language skills would be a plus;
  • Strong communication and presentation skills;
  • Excellent team player.

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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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