Director Global Regulatory Affairs Development Pipeline (Oncology)

BioNTech • Gaithersburg, MD

28d

About The Position

Act as the Global Regulatory Lead for assigned development projects by defining and executing the Regulatory Strategy including the HA interaction strategy and developing the storyline for regulatory applications and dossiers during product development up to marketing authorisation. Your main responsibilities are:

Requirements

• University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 9+ years of relevant experience
• 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

Responsibilities

• 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. marketing authorization
• Define storyline for regulatory application and dossiers through product development up to marketing authorization
• Coordinate preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, MAA, variations)
• Contribute to the setup, adjustment and continuous optimization of regulatory processes, systems and interfaces
• Supervise vendors active in regulatory affairs on behalf of BioNTech
• Monitor of 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees