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

CureVac SE 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, our office in Amsterdam or Belgium, we are currently looking to recruit a 

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

Your Responsibilities:
 

• Proactively manages regulatory CMC aspects of projects including overseeing preparation and submission of CMC submissions appropriate to the phase of development
• Coordinates and collaborates in creating 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.
• Maintains awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics with a focus on biopharmaceuticals
• Incorporates regulatory requirements in pre-clinical and clinical development
• Develops and maintains excellent relationships with regulatory authorities, internal functional groups, and corporate partners

Your Qualifications: 
 

• Undergraduate degree from a college or university in natural sciences, biotechnology, pharmacy, veterinary medicine or medicine; advanced degree would be a plus
• First experience with CMC in pharmaceutical industry; preferably in biopharmaceuticals and regulatory affairs
• Basic knowledge of ICH-CMC regulatory requirements for biopharmaceuticals and ability to apply knowledge both strategically and operationally
• Elementary understanding of EMA, FDA and international CMC regulations
• Strategic mindset, innovative yet pragmatic/solution-oriented thinking, and attention to detail with a strong orientation to quality
• 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 in German and English 

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 SE

Human Resources
Christina Glass 
Friedrich-Miescher-Straße 15
72076 Tübingen