Associate Director Global Regulatory Operations

Overview

Associate Director Global Regulatory Operations at BioNTech SE. Location: 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 with 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.

Responsibilities

• Manage submissions of EU CTAs according to project plans and as defined in SOPs and work instructions, including entering data and uploading documents, and monitoring CTIS for Requests for Information (RFIs) and other authorities’ responses in close alignment with the relevant team members. Maintain CTAs in CTIS and perform 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 setup and maintenance of governance structures and connect to software solutions (CTIS and BioNTech\'s Regulatory information and document management system, other safety and clinical systems).
• Improve processes related to the EU CTR regarding compliance and key deliverables for CTA submission using CTIS; maintain cross-functional exchange and alignment with external users such as service providers.
• Continuously monitor and adjust BioNTech\'s processes in line with EMA\'s CTIS User Management concept and its evolution. Identify training needs for internal and external users, and design and provide relevant trainings.

Qualifications

• Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent.
• Minimum of 5 years of professional 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 working in complex multi-stakeholder environments according to cross-functional processes.
• Experience with global software solutions for planning, creating and tracking Clinical and/or Regulatory submissions.
• Proficiency in Microsoft Office, Adobe Acrobat, SharePoint.
• Result- and goal-oriented with excellent communication skills in English.

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 determined by the specific role, location, and the selected candidate’s qualifications and experience. Note: Availability, eligibility, and design of benefits may vary by location. Final requirements for the use of benefits are based on internal policies and applicable law.

How to apply

Apply now by sending your application documents including Curriculum Vitae, copies of degree certificates and professional certificates, motivation letter, and contact details via our online form. Applications submitted via the online form only will be considered. A background check may 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 HireRight and inform you accordingly.

We look forward to receiving your application.

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