Associate Director Global Regulatory Operations

Mainz, Germany; Munich, Germany   |   full time   |   Job ID: 9799 

You will define and manage Regulatory Operations activities of EU Clinical Trial Application (CTA) submissions in the Clinical Trials Information System (CTIS) in compliance to the EU Clinical Trial Regulation (EU CTR). Support the strategic refinement, coordination, and continuous improvement of cross-functional processes for CTAs and clinical trial maintenance in compliance with the EU CTR.

Your main responsibilities: 

• Manage submissions of EU CTAs according to project plans and as defined in SOPs and work instructions, including entering of data and upload of documents, as well as monitoring of CTIS for Requests for Information (RFIs) and other authorities’ responses in close alignment with the relevant team members. Further you will be responsible for maintenance of CTAs in CTIS and CTA monitoring and result reporting
• Ensure the EU CTR compliant use of CTIS within a multi-stakeholder team, following the defined roles and responsibilities for Global Regulatory Operations (GRO) and Global Regulatory Affairs (GRA)
• Support the strategic set up and maintenance of governance structures and support the connection to software solutions (CTIS and BioNTech's Regulatory information and document management system, other safety and clinical systems)
• Improvement of processes related to the EU CTR regarding compliance and key deliverables for CTA submission using CTIS. This further includes the constant exchange and alignment cross-functionally and with external user such as service providers
• Continuously monitor and adjust BioNTech´s processes under consideration of EMA´s CTIS User Management concept and its evolution. Identify training needs for internal and external users, as well as design and provide relevant trainings

BioNTech, our story. What you have to offer:

• Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
• Minimum of 5 years professional working experience in a relevant field in the pharmaceutical industry
• Sound understanding of processes for CTAs under the EU-CTR including relevant timelines, and deliverables
• Ideally experience in submitting and managing CTAs in CTIS
• Experience in working in complex multi-stakeholder environments according to cross-functional processes
• Experience in working with global software solutions for planning, creating and tracking of Clinical and/or Regulatory submissions
• Proficiency in Microsoft Office, Adobe Acrobat, Sharepoint
• Result-and goal-oriented
• Excellent communication skills in English

Your Benefits:

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.