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BioNTech SE
Biologist as Regulatory Affairs Manager (m/f/d)
• Cambridge, 02139
Homeoffice möglich
Senior Director, Global Regulatory Affairs Development Pipeline, Cell
Therapy Cambridge, US full time Job ID:5459 Act as global regulatory lead for assigned development projects, specifically within the cell and gene therapy portfolio. Define and execute Regulatory Strategy from clinical development up to (including) Marketing Authorisation Application 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. 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. Represent GRA in cross-functional internal initiatives for process [...] 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/ 7Parental 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 Insuranceand more More details to be shared. 43408545 [...]
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