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

Senior Manager Regulatory Affairs (f/m/d)

(Reference No. OP2106)

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Responsibilities

  • Develop and implement regulatory submission strategies for assigned products
  • Represent the Regulatory Affairs function in cross-functional development program teams and support the teams in all regulatory matters
  • Manage all operational aspects of the Regulatory Affairs Function (e.g. processes and timelines) while ensuring regulatory conformance
  • Lead the preparation and conduct of different direct interactions like scientific advice meetings, deficiency meetings, phone contacts etc., with the Competent Authorities
  • Interact with national or global Competent Authorities (FDA, EMA) during the product development and registration by coordinating 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 to 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 3 years experience in Regulatory Affairs, drug development or drug product maintenance, in more than one region across the globe
  • 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).

July 2021

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