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

Regulatory Affairs Manager (f/m/d)

(Reference No. OP1905)

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Responsibilities

  • Manage operational aspects of the Regulatory Affairs Department while ensuring regulatory compliance
  • Represent the Regulatory Affairs function in the cross-functional development program teams and support the team with writing and editing regulatory documents in compliance with eCTD requirements
  • Support the Director Regulatory Affairs in developing and implementing the development regulatory strategies for the submission of new programs
  • Prepare all types of regulatory submission documents relevant to the company’s product portfolio, such as CTA applications, IND applications, clinical-trial and orphan-drug applications in EU and USA. Coordinate the technical content of those documents and ensure that timelines are met
  • Support/lead the preparation of different types of meetings with the Regulatory Agency (scientific advice, PIND, EOP1, etc.)
  • Collaborate with subject matter experts/technical functions to ensure delivery of high-quality documentation to meet global regulatory expectations
  • Drive day-to-day interactions with global health authorities for all routine regulatory correspondence and coordinate the interactions with vendors, CROs, and consultants
  • Prepare and/or update internal procedures/SOP for continuous regulatory process improvements

Requirements

  • Master or PhD in natural sciences or equivalent education
  • At least 3 years of Regulatory Affairs experience in a biotechnology or pharmaceutical industry environment
  • Hands-on experience in preparing and compiling regulatory submission documents e.g., CTAs, INDs, briefing documents, orphan drug applications, annual reports/DSURs, etc.
  • Very good understanding of international regulatory requirements and guidelines
  • Experience with submissions/filings in both EU and US would be advantageous
  • Experience with biological products in oncology is a plus
  • 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 skills

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).

October 2019

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