BioNTech SE

Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy. 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.. Contribute to the content strategy and define the storyline for regulatory applications and dossiers through product development and to marketing authorization.. 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.. Good understanding of oncology and immunology; experience in supporting cell therapy products through clinical development

regulatory affairs

Open for hire at one of the following locations – Cambridge Erie Street, Berlin Gebäude 03.51, Gaithersburg, London, Mainz Goldgrube. - Job ID: 5459 Become a member of the BioNTech Family! As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy Primary responsibilities include: <ul><li> Act as global regulatory lead for assigned development projects, specifically within the cell and gene therapy portfolio. </li><li> Define and execute Regulatory Strategy from clinical development up to (including) Marketing Authorisation Application </li><li> 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. </li><li> 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. </li><li> 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 </li><li> Define and oversee oversight plans for vendors active in regulatory affairs on behalf of BioNTech </li><li> 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. </li><li> Develop and establish transparent relationships with Regulatory agencies for the assigned projects. </li></ul> What you have to offer. Requirements: <ul><li> University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 15+ years of experience in relevant roles/positions </li><li> Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities </li><li> Good understanding of oncology and immunology; experience in supporting cell therapy products through clinical development </li><li> Knowledge of multidisciplinary functions involved in drug development </li><li> Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Oncology </li><li> Very structured, accurate and team-oriented way of working </li></ul> Preferred Requirements: Proficient in German Benefits for you 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. Click here to find out more about what we do, the careers we offer and also the benefits we provide. 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. Have we kindled your pioneering spirit? This vacancy is to be hired at one of the following locations – Cambridge Erie Street, Berlin Gebäude 03.51, Gaithersburg, London, Mainz Goldgrube . Apply now for your preferred job and location through our careers site . <ul><li>BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!</li></ul>

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