Regulatory Affairs Manager (f/m/d)

h3Regulatory Affairs Manager (f/m/d) /h3 pBavarian Nordic Berna GmbH Vacant since : Number of jobs : 1 3174 Thörishaus (BE) 100% Immediately Permanent /p pJoin 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. /p pThis 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. /p h3Your responsibilities /h3 ul liLead regulatory activities for assigned lifecycle management projects, including global product expansions /li liDevelop and execute regulatory strategies for post-approval activities, ensuring alignment with business objectives and global regulatory requirements /li liPrepare, coordinate and submit high-quality regulatory documentation, including briefing packages, variations, supplements and marketing authorization submissions /li liAct as the Regulatory Affairs lead within cross-functional project teams, providing strategic guidance throughout post-authorization processes /li liCoordinate responses to health authority questions and regulatory review procedures, ensuring timely and compliant interactions with regulatory agencies worldwide /li liMonitor and interpret evolving regulatory requirements, guidelines and legislation, communicating relevant updates to stakeholders and supporting organizational compliance /li liContribute to regulatory operational excellence through process improvements, and the development and maintenance of Regulatory Affairs SOPs and work instructions /li /ul h3About you /h3 ul liMaster’s degree in Life Sciences (e.g., Biology, Molecular Biology, Biochemistry, Pharmacy) or a related scientific discipline /li liMinimum of 5 years of Regulatory Affairs experience within pharmaceutical drug development, ideally in a global environment /li liStrong understanding of regulatory submission and approval processes, including experience with major regulatory frameworks such as EU and/or US /li liIdeally experience supporting the registration and lifecycle management of biologic products /li liSolid knowledge of pharmaceutical regulations and regulatory intelligence, with the ability to interpret evolving requirements and provide sound regulatory guidance /li liExcellent communication and stakeholder management skills, with the ability to collaborate effectively across cross-functional and international teams; fluent in written and spoken English /li liHighly 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 systems /li /ul h3What We Offer /h3 ul liA high-ownership role with direct influence on operational performance, giving you clear responsibility and visible impact /li liCollaboration with international suppliers and cross-functional teams, working in a dynamic and global environment /li liProfessional development and growth opportunities within a forward-thinking and innovation-driven organization /li liA supportive team culture and a flexible working environment that values trust, autonomy and work-life balance /li /ul pAre you ready to join us in our mission? /p pBavarian 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. /p pBavarian 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. /p pFor more information, visit /p ul libWork location /b 3174 Thörishaus (BE) /li libWorkload /b 100% /li libEmployment start /b Immediately /li libEmployment duration /b Permanent /li /ul ul libQualification /b skilled /li libWork experience /b More than 3 years /li libEducation /b Master’s degree from a university or equivalent /li /ul ul libEnglish /b Orally : Very good knowledge Written : Very good knowledge /li /ul ul libBy online /b Online form /li /ul #J-18808-Ljbffr