Regulatory Affairs Manager (f/m/d)

Join our Regulatory Affairs team and play a pivotal role in bringing innovative biologic products to patients worldwide. As Regulatory Affairs Manager located in Martinsried (Munich), Törishaus (Bern) or Kvistgaard, you will lead global regulatory activities across product registration and lifecycle management, working closely with cross-functional teams and health authorities. This is an exciting opportunity for an experienced regulatory professional to shape regulatory strategies, drive successful submissions, and contribute to the delivery of high-quality healthcare solutions. Occasional travel should be expected.Your responsibilitiesLead regulatory activities for assigned lifecycle management projects, including global product expansionsDevelop and execute regulatory strategies for post-approval activities, ensuring alignment with business objectives and global regulatory requirementsPrepare, coordinate and submit high-quality regulatory documentation, including briefing packages, variations, supplements and marketing authorization submissionsAct as the Regulatory Affairs lead within cross‑functional project teams, providing strategic guidance throughout post‑authorization processesCoordinate responses to health authority questions and regulatory review procedures, ensuring timely and compliant interactions with regulatory agencies worldwideMonitor and interpret evolving regulatory requirements, guidelines and legislation, communicating relevant updates to stakeholders and supporting organizational complianceContribute to regulatory operational excellence through process improvements, and the development and maintenance of Regulatory Affairs SOPs and work instructionsAbout youMaster’s degree in Life Sciences (e.g., Biology, Molecular Biology, Biochemistry, Pharmacy) or a related scientific disciplineMinimum of 5 years of Regulatory Affairs experience within pharmaceutical drug development, ideally in a global environmentStrong understanding of regulatory submission and approval processes, including experience with major regulatory frameworks such as EU and/or USIdeally experience supporting the registration and lifecycle management of biologic productsSolid knowledge of pharmaceutical regulations and regulatory intelligence, with the ability to interpret evolving requirements and provide sound regulatory guidanceExcellent communication and stakeholder management skills, with the ability to collaborate effectively across cross‑functional and international teams; fluent in written and spoken EnglishHighly detail‑oriented with strong analytical skills, including the ability to evaluate scientific data and translate complex information into high‑quality regulatory documentation; proficient in standard computer applications and digital systemsWhat We OfferA high‑ownership role with direct influence on operational performance, giving you clear responsibility and visible impactCollaboration with international suppliers and cross‑functional teams, working in a dynamic and global environmentProfessional development and growth opportunities within a forward‑thinking and innovation‑driven organizationA supportive team culture and a flexible working environment that values trust, autonomy and work–life balanceAre you ready to join us in our mission?Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.For more information, visit Bavarian Nordic a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-savings vaccinesOur 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. All qualified applications will receive consideration for employment and will not be discriminated against on the basis of race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.For more information visit #J-18808-Ljbffr