Loading...
 

Senior Manager (f/m/d) Global Regulatory Affairs

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 Frankfurt we are currently looking to recruit a

 

Senior Manager (f/m/d) Global Regulatory Affairs

 

 

Your responsibilities:

 

  • Provide and support regulatory strategy and provide day-to-day regulatory support for preclinical and clinical product development in collaboration with internal functions and partners
  • Incorporate regulatory requirements in preclinical and clinical development
  • Represent regulatory affairs on assigned project teams
  • Plan, prepare and coordinate health authority interactions such as scientific advice or pre-IND meetings during the product development process in collaboration with other functions
  • Draw up and coordinate generation of high-quality regulatory documents for submission to health authorities e.g., CTAs and INDs
  • Coordinate response/respond to deficiency letters from health authorities
  • Identify new regulatory requirements, monitor compliance and analyze impact
  • Incorporate new regulatory developments in the development strategy and internal work processes, including generation and revision of SOPs and work instructions in collaboration with other relevant functions
  • Support due diligence and partnering activities

 

Your qualifications:

 

  • University or college degree, and preferably a doctorate in the field of natural sciences, biotechnology, pharmacy, veterinary medicine or medicine
  • Professional experience with regulatory affairs with the health authorities at national and international level, or in the pharmaceutical industry, including knowledge of licensing requirements and legislation
  • Knowledge and understanding of European, US and other international regulations as well as the ability to assess regulatory risks/benefits and applicable guidance
  • Experience in drawing up and coordinating preclinical and clinical documents for submission to the health authorities (e.g., CTA, IND, scientific advice briefing books, etc.)
  • Regulatory and/or scientific/clinical experience in the area of biologics, ATMPs, vaccines, infectious diseases and oncology is an advantage
  • Ability to work independently in a structured way
  • Excellent written and oral communication skills 
  • Excellent personal skills with a team-oriented approach and the ability to work across functions and departments
  • Business-fluent written and spoken English and preferably also German
     

 

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
Christina Glass 
Friedrich-Miescher-Straße 15
72076 Tübingen