Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy

Cambridge, US   |   full time   |   Job ID: 5459 

Primary responsibilities include:

1. Act as global regulatory lead for assigned development projects, specifically within the cell and gene therapy portfolio.
2. Define and execute Regulatory Strategy from clinical development up to (including) Marketing Authorisation Application
3. Define the strategy for regulatory interactions, lead regulatory meetings 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 including. marketing authorization.             
4. Contribute to the content strategy and define the storyline for regulatory applications and dossiers through product development and to marketing authorization. Coordinate preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, MAA, variations) as needed.    
5. Represent GRA in cross-functional internal initiatives for process improvement and interactions with internal and external stakeholders, including collaboration partners. Set up, adjustand continuly optimization regulatory processes, systems and interfaces
6. Define and oversee oversight plans for vendors active in regulatory affairs on behalf of BioNTech
7. Monitor  changes and evolution in the regulatory landscape for relevant cell and gene therapy products and/or relevant product classes; analyze the impact of new regulations on assigned projects; participate in or propose initiatives to influence regulatory landscape.
8. Develop and establish transparent relationships with Regulatory agencies for the assigned projects.         

What you have to offer. 
Requirements:

1. University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 15+ years of experience in relevant roles/positions
2. Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities
3. Good understanding of oncology and immunology; experience in supporting cell therapy products through clinical development
4. Knowledge of multidisciplinary functions involved in drug development
5. Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Oncology
6. Very structured, accurate and team-oriented way of working

Preferred Requirements: Proficient in German

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.
 

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US location and simply send us your documents using our online form.

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 Recruiter.