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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 improvement and interactions with internal and external stakeholders, including collaboration partners. Set up, adjustand continuly optimization regulatory processes, systems and interfaces Define and oversee oversight plans for vendors active in regulatory affairs on behalf of BioNTech 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 [...] regulatory landscape. Develop and establish transparent relationships with Regulatory agencies for the assigned projects. Requirements:University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 15+ years of experience in relevant roles/ positions Experience in regulatory strategy
planning and proven ability to plan, coordinate and lead activities Good understanding of oncology and immunology; experience in supporting cell therapy products through clinical development Knowledge of multidisciplinary functions involved in drug development Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Oncology Very structured, accurate and team-oriented way of working Preferred Requirements: Proficient in German 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 [...]
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