Design. Progress. Together.
CureVac AG is a biopharmaceutical company researching and developing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on innovative cancer immunotherapies, prophylactic vaccines and molecular therapies. Currently, about 470 RNA people are striving to achieve our main goal: To bring the first mRNA-based drug worldwide to the market.
To strengthen our team in Frankfurt, we are currently looking to recruit a
Senior Regulatory Documentation Specialist (f/m/d)
- Preparing regulatory documents for submission to regulatory authorities within subject area (clinical/safety) with accountability for delivering regulatory documents and contributing to the functional excellence of regulatory documentation through process management
- Managing compilation and review of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
- Planning and creation of timelines for the production of assigned documents and dossiers and tracking of their timely delivery and reviewing by assigned Writing/Editing/Review team
- Ensuring proper planning and resourcing of all documents assigned to Writing/Editing Team including work to be outsourced
- Preparing specifications for outsourced work (writing/review of documents) and serving as liaison for project purposes
- Ensuring compliance with documentation quality standards and regulatory requirements across all documents when managing timely delivery of high-quality documentation for a product/within a clinical dossier
- Actively contributing to best practices and continuous improvement within Regulatory Documentation
- Representing the group in functional and cross-functional initiatives/projects when required
- Acting as a mentor to new members/less experienced members of the Documentation group
- In addition, assumes the responsibilities of a Regulatory Documentation Specialist, i.e. supports the set-up of systems and databases for archiving regulatory information
- Degree in life sciences or other relevant field, Phd or equivalent preferred
- At least 5 years of project management experience in regulatory documentation generation
- Experience in regulatory affairs operations and project management or related functions in drug development, knowledge of international regulations, and previous experience of managing and generating high-quality regulatory documentation
- Strong knowledge about IT systems, electronic document management systems, databases, publishing systems etc. relevant for regulatory affairs
- Proven leadership experience
- Consistently achieves multiple tasks and goals on-time
- Strong interpersonal, influencing and verbal communication skills
- Demonstrated clear, high-quality scientific writing style in English
- Ability to work effectively in a team environment, establishes strong collaborative relationships, resolves conflict by creating an atmosphere of openness and trust
- Fluency in English and German
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.