Regulatory Affairs Manager CMC Biologics (f/m/d)

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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, about 500 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

Regulatory affairs manager CMC Biologics (f/m/d)
Kennziffer: 1901-2101

Your responsibilities:

  • Proactively manages regulatory CMC aspects of projects, including overseeing preparation and submission of CMC regulations appropriate to the phase of development 
  • Draws up and coordinates 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
  • Manages interactions with regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions which contain CMC information
  • Maintain awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics with a focus on Biologics
  • Incorporates regulatory requirements in pre-clinical and clinical development 
  • Develops and maintains excellent relationships with regulatory authorities, internal functional groups and corporate partners
  • Implements 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:

  • Undergraduate degree from a college or university in natural sciences, biotechnology, pharmacy, veterinary medicine or medicine; advanced degree would be a plus
  •  3+ years' experience with CMC regulations in the pharmaceutical industry Extensive knowledge of US and ICH CMC regulatory requirements for biological drugs and ability to apply knowledge both strategically and operationally to resolve regulatory issues 
  •  Knowledge/Understanding of EMA, US and international CMC regulations and guidance, and ability to assess regulatory risks/benefits and guidance as they apply to CMC experience in CMC development and/or production/control of biologicals and/or ATMPs with sound scientific understanding of products and processes
  • Strategic mindset, innovative yet pragmatic/solution-oriented thinking, and attention to detail with a strong orientation towards quality
  • Abilities to advise stakeholders on RA CMC strategies and provide training where applicable
  • Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities  
  • Business-fluent written and spoken German and English

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
Dr. Alma Andresen
Friedrich-Miescher-Straße 15
72076 Tübingen