Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our highly motivated Operations-Team in Heidelberg, Germany, we are looking for a full-time

Director Regulatory Affairs (f/m/d)

(Reference No. OP2106)

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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

Opportunity

The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and collegial team.
For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).

January 2022

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