Director Global Regulatory Affairs (m/f/d)
Mainz, Germany | full time | Job ID:9340
You will act as the Global Regulatory Lead for assigned development projects by defining and executing the Regulatory Strategy including the Health Authority Interaction strategy and developing the storyline for regulatory applications and dossiers during product development up to marketing authorization (optional: act as US IND agent for assigned projects).
Act as Global Regulatory Lead for assigned development projects and define and execute the Regulatory Strategy from clinical development up to (including) marketing authorization.
Define the strategy for regulatory interactions for the assigned projects. Plan, prepare and conduct interactions with national authorities and sovra-national agencies (e.g. MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development incl. market authorization.
Define the storyline for regulatory applications and dossiers through product development up to marketing authorization.
Coordinate preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, BLA/MAA).
Contribute to the setup, adjustment and continuous optimization of regulatory processes, systems and interfaces; represent GRA in cross-functional initiatives for process improvement and with collaboration partners
Supervision of vendors active in regulatory affairs on behalf of BioNTech.
Monitor changes and evolution in the regulatory landscape for relevant product and/or product classes; analyze the impact of new regulations on assigned projects; contribute to build transparent relationships with Regulatory agencies for the assigned projects.
University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 9+ years of working experience in Regulatory Affairs in relevant roles/positions
Experience in the development of antibody- and ADC-based cancer therapies; novel-novel combination therapy and companion diagnostic development experience a plus
Team-oriented and solution-oriented mindset is expected
Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities
Knowledge of multidisciplinary functions involved in drug development
Business fluent English is a must
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.