CMC Regulatory Affairs Senior Manager

<p>At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial product portfolio includes market-leading vaccines against smallpox, mpox, rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&amp;D innovation, manufacturing, and commercialization, striving to improve people's health and quality of life worldwide, protecting our tomorrow. Join us in our mission to make a difference. Reporting to the Senior Director of Regulatory Affairs, CMC, you will be the point of contact for two of our drug products within Regulatory Affairs CMC. The position is in Kvistgaard.</p><p></p><p><b>The role</b><br/>You will be responsible for the submission and approval of the Technical Transfers projects and the lifecycle management (LCM) activities related to the drug products including compliance with applicable regulations. As the landscape changes, you will also be responsible for the adaptation of the Regulatory Strategies for the transfers and negotiations with regulatory agencies. Additionally, you will be responsible for the drug product strategy for Japan and execution hereof.</p><p></p><p>Other key tasks:</p><ul><li><p>Coordination and project management of drug product-related tasks/submissions</p></li><li><p>Cross-organizational involvement and alignment</p></li><li><p>Regulatory sparring partner for team and CMC organization</p></li><li><p>Responsible for the drug product scientific advice meetings</p></li><li><p>Driver of DP submissions</p></li><li><p>Stakeholder Management</p></li><li><p>Provide input to departmental goals that align with functional strategy</p></li><li><p>Contribute to the regulatory affairs processes<br/> </p></li></ul><p><b>Skills and requirements</b><br/>You hold a Ph.D. or a master’s degree in Pharmaceutical Sciences, Chemical Engineering, or a related field. This critical role requires 8+ years of industry experience in Regulatory Affairs, with a focus on biologics, and involves close collaboration with agencies and experienced managers.</p><p></p><p>You should have experience and a clear understanding of the overall drug development process for vaccines, including manufacturing and global requirements for commercialized products. Strong project management and communication skills, a great sense of accountability, and the ability to thrive in an environment that values employee engagement and openness to change are essential. Additionally, a high level of proficiency in Danish, both verbal and written, is required.</p><p></p><p><b>We offer </b></p><p>You will work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion for making a difference. We offer a dynamic and flexible work environment and an opportunity to develop your personal and academic competencies.</p><p></p><p><b>Caught your interest?</b></p><p>Please contact Senior Director Rehana Mukhtar via <a href="mailto:remu@bavarian-nordic.com" rel="noopener noreferrer" target="_blank"><span>remu@bavarian-nordic.com</span></a>, if you have any questions regarding the position. Applications submitted via email will not be considered but must be submitted through our designated application platform.</p><p></p><p>We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.</p><p></p><p>Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.</p><p><a href="https://www.bavarian-nordic.com/" rel="noopener noreferrer" target="_blank"><span>www.bavarian-nordic.com</span></a></p><p></p><p>#LI-CK1</p>