Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Manager, Global Regulatory Affairs - US Strategy Become a member of the BioNTech Family! Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities. Senior Manager, Global Regulatory Affairs - US Strategy Your responsibilities may include: Advise on US FDA procedures, requirements and administrative documentation Establish and maintain transparent and collaborative relationship with the Agency across all projects and for overarching non-project specific topics and initiatives Support the preparation and the review of regulatory documents and forms part of IND / BLA / NDA, expedited regulatory programs (BTD, PRIME, etc), and other regulatory filings to US FDA Secure timely submissions to FDA, in alignment with Global Regulatory Lead(s) (GRLs) and Regulatory Operations Plan and manage regulatory agency interactions, align with GRLs on communication strategy and coordinate correspondence with the Agency, proactively preparing the team and addressing any queries from the agency while facilitating effective communication practices Collaborate with Global Regulatory Leads on planning and implementation of the regulatory strategy for the assigned projects Establish and maintain proper regulatory processes for the regulatory handling and lifecycling of clinical trials, in alignment with Global Regulatory Operations and Clinical Research Organizations as appropriate, to ensure regulatory documentation is properly maintained according to internal SOPs, regulatory requirements and best practice What you have to offer. University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)or professional certification (e.g., RAC) Minimum 5years professional working experience in Clinical Regulatory Affairs Extensive experience working with Health Authorities, and in particular with the US FDA, and submitting regulatory filings Basic knowledge of regulatory requirements and procedures in the EU/EEA and US throughout the product’s life cycle Experience working with collaborators or external partners such as regulatory consultants, contract research organizations (CRO) and 3rd parties preferred Knowledge of multidisciplinary functions involved in clinical trials and pharmaceutical development Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Cancer and Infectious diseases Effective communicator with ability to negotiate with internal stakeholders and external partners Familiarity with eCTD and regulatory document management systems Thrives in a fast-paced environment with ability to manage multiple products and competing timelines Benefits for you: BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. 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, STD and LTD Insurance Health & Wellness, including free onsite gym access Adoption & Surrogacy Assistance Vacation and Unlimited Sick Time Holidays and Floating Holidays, including discretionary winter shutdown 401(K) Plan with Significant Company Match Tuition Reimbursement and Professional Development Commuting Assistance and subsidized parking Discounted Home and Auto Insurance Pet Insurance Plus more benefits that will be shared upon hire! Have we kindled your pioneering spirit? Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form. * 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! Provider Description Enabled SAP as service provider "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor Provider Description Enabled YouTube #J-18808-Ljbffr