Executive Director Legal - Global Regulatory Law - #1799311

London, United Kingdom | full time | Job ID: 9195

This position will be based in London, UK. There will be an expectation for regular contact and travel to the German headquarter in Mainz.

The Executive Director Legal - Global Regulatory Law will be a key member of the BioNTech global legal team and will be important to the successful execution of BioNTech’s development plans and anticipated oncology product launches in the United States and beyond. This role will support multiple business partners, including Global Regulatory Affairs, the Global Development Organization, Medical, Safety & Pharmacovigilance, Quality, Government Affairs, Business Development and Alliance Management and other cross-functional teams to provide guidance and counsel on matters related to regulatory law compliance in the biopharmaceutical industry.

Your main responsibilities include:

• Provide legal advice and counselling on a broad range of regulatory law topics including: regulatory exclusivities, regulatory strategies, product classification, orphan medicinal products, advanced therapy medicinal products, medical devices and IVDs (including software), pediatric obligations and rewards, GxP compliance and inspection support, regulatory reporting obligations, labelling, freedom of information, and compassionate use
• Support the Transactions Legal Team and the Business Development and Alliance Management Teams on regulatory law topics in the context of deals
• Provide legal advice on artificial intelligence as it relates to medicinal products and medical devices
• Support the data privacy team on the interface between clinical trials, pharmacovigilance and data privacy
• Support the dispute resolution on regulatory law topics including in relation to product liability and government investigations
• Provide training on regulatory law topics to key internal clients and serve as the primary legal support and contact for the Global Regulatory Affairs team
• Serve as a legal representative on cross-functional committees such as the Executive Safety Committee, Risk Evaluation Committee, and Labelling and Launch Readiness teams
  
  

General responsibilities will include:

• Represent Legal on cross-functional teams, including by demonstrating leadership, identifying legal issues and considerations, evaluating possible options and solutions, and providing recommendations for addressing critical issues so that business and legal objectives are met
• Proactively identify areas where outside local legal counsel is necessary; work closely with outside counsel to obtain local legal guidance, and subsequently advise internal business partners
• Work collaboratively and creatively with internal clients by clearly and effectively rendering practical and timely legal advice on complex issues/concepts
• Advise on the interpretation of legal documents and applicable laws and regulations in a manner that provides practical legal advice while properly managing risk to the organization
• Keep informed of new laws, regulations, codes of practice and industry trends affecting the organization, and assist with development of policies and training as needed
• Generally, collaborate closely with the Corporate Compliance team and other Legal colleagues to provide legal support to the organization
  
  

What you have to offer:

• Juris Doctor from an accredited university / law school; active membership and in good standing in an accredited law or bar society
• Oncology launch and/or global launch experience is desirable
• Minimum 15 years prior legal experience, with 12+ years life science / pharmaceutical experience
• High degree of personal ethics, integrity and accountability
• Candidates must have the soft skills to navigate a complex and evolving organization and be able to develop policies for the organization
  
  

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.