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Manager Regulatory Affairs CMC (f/m/d)

Design. Progress. Together.

 

CureVac AG is a global biopharmaceutical company researching and developing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on prophylactic vaccines, innovative cancer immunotherapies and protein-based therapies. Currently, all RNA people are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market.

 

To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit a

 

Manager Regulatory Affairs CMC (f/m/d)

 

Your responsibilities:

 

  • Taking responsibility for regulatory CMC strategies and day-to-day regulatory support of our therapeutic area teams, technical development and manufacturing departments
  • Advising the program teams and the CMC departments on the planning of health authority interactions during the product development process
  • Drawing up and coordinating high-quality regulatory documents (e.g. CMC sections of briefing books for health authority interactions, IMPDs, INDs)  in close collaboration with the individual CMC functions
  • Preparing and participating in health authority interactions such as scientific advice or pre-IND meetings
  • Monitoring compliance with regulatory requirements and schedules
  • Incorporating regulatory requirements in pre-clinical and clinical development
  • Responding to deficiency letters from health authorities
  • Supporting due diligence and partnering activities
  • Identifying new regulatory requirements through ongoing further training
  • Incorporating new regulatory developments in the development strategy and internal work processes, including drawing up and revising work instructions in collaboration with the relevant functions

 

Your qualifications:

 

  • Degree from a college or university and a doctorate in the field of natural sciences, biotechnology, pharmacy, veterinary medicine or medicine
  • Professional experience with regulatory affairs at national and international level with the health authorities or in the pharmaceutical industry, including knowledge of licensing requirements and legislation with special focus on CMC
  • Knowledge/Understanding of EMA, US and international CMC regulations, and guidance and ability to assess regulatory risks/benefits and applicable guidance as they apply to CMC
  • Experience in drawing up and coordinating pre-clinical and clinical documents for submission to the health authorities (e.g. CMC part of a CTA and IND, Module 3 documents, CMC document as part of scientific advice briefing books, IMPD etc.)
  • Business-fluent written and spoken English and German
  • Ability to work independently in a structured way and excellent communication skills
  • Regulatory and/or scientific/clinical experience in the area of biologics, ATMPs, vaccines and oncological drugs is an advantage

 

 

We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.

Design your future with us – become part of the RNA people!   

We look forward to receiving your application via our CareerPortal.

 

CureVac AG

 

Human Resources
Alexander Siller 
Friedrich-Miescher-Straße 15
72076 Tübingen