Careers

We provide an attractive working environment
for highly motivated and committed employees
in a rapidly growing company.

 
 
     
 
  Job Advertisement  
     
  Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK- and T-cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases.  
     
 

To strengthen our highly motivated team, we are looking for a

Senior Regulatory Affairs Manager (m/f)
(Reference No. OP02)

 
 

Responsibilities:

Key accountabilities include:

  • Lead regulatory strategy and operational implementation of development programs
  • Prepare and compile the Common Technical Document (CTD) for dossier submission according to regulatory requirements of different regions (e.g. EU, USA, Canada, Japan)
  • Coordinate the dossier submission process
  • Identify the required documentation for submissions based on a deep knowledge of the respective regulatory environment and negotiate the delivery of documents in accordance with the program timelines
  • Review and write high-quality Regulatory Affairs documentation during development and product registration based on agreed regulatory strategies
  • Assure technical congruence and regulatory compliance
  • Meet agreed timelines and publishing requirements
  • Build and maintain a sustained liaison with Regulatory Authorities
  • Lead preparation and conduct of Regulatory Authority meetings in close collaboration with the program team
    Provide:
    • Regulatory input and support of development programs
    • Information on regulatory requirements of various authorities
    • Regulatory input to the preparation of development documents (e.g. input to development plans, IMPDs, briefing books, clinical study protocols)
  • Develop regulatory strategies for the submission of new programs as well as provide input on general development concepts
  • Prepare responses to health authority questions during development and registration
  • Monitor and lead the regulatory life cycle management process for the development programs
  • Keep knowledge up to date with regard to guidelines and regulatory trends
  • Ensure working compliance with the respective SOPs
  • Responsibility for adherence of expenses to budget (regulatory affairs and project related)

Required Qualification:

  • Ph.D. in natural sciences or equivalent education
  • 5 or more years of Regulatory Affairs experience in drug development in the biotechnology or pharmaceutical industry environment
  • Excellent understanding of regulatory requirements and guidelines for filings worldwide and critical evaluation of emerging requirements and guidelines for new drugs
  • Excellent communication and presentation skills
  • Fluent in oral and written English
  • 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 65307-75, E-mail: s.hering@affimed.com).

November 2017


 
 
  Apply now by use of Reference No. OP02
 
 



 
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