Sr Manager Regulatory Affairs
Sr Manager Regulatory Affairs
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Job Description
Job Title: Sr Manager Regulatory Affairs
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Protecting Our Tomorrow
At Bavarian Nordic we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox/mpox vaccines and our commercial product portfolio contains marketleading vaccines against rabies tickborne encephalitis typhoid fever and cholera. We excel in R&D innovation manufacturing and commercialization. We aim to improve health and quality of life for children and adults around the world – protecting our tomorrow. We hope that you will share this mission with us.
Senior Manager Regulatory Affairs
Would you like to join a team of global Regulatory Affairs professionals dedicated to the development and licensure of innovative vaccines Great! Because we are looking for a Senior Manager Regulatory Affairs to help realize our aspiration to save and improve lives by developing innovative vaccines designed to unlock the power of the immune system.
We are a fully integrated global vaccine company engaged in the development of products for serious infectious diseases (e.g. chikungunya and equine encephalitis) and our commercial product portfolio contains marketleading vaccines against smallpox mpox rabies cholera typhoid fever and tickborne encephalitis as well as an Ebola vaccine licensed to Janssen.
Boost our team
- The Global Regulatory Affairs team is located across multiple countries (United States Canada Denmark Germany Switzerland)
- We have teams covering RA development RA lifecycle and maintenance RA CMC and RA operations
- We are driven by regulatory excellence and are committed to improving and saving lives through innovative vaccines
Your Responsibilities
Our vaccines make a real difference to people and no matter your role we all contribute to protecting lives every day. This is how your work matters the Senior Manager Regulatory Affairs is responsible for:
- Regulatory management of product development registration and postapproval activities this includes assisting with development and implementation of regulatory strategies for assigned BN products
- Serving as primary liaison with US FDA and establishing effective working relationships with Health Authority staff; in addition this position will lead formal interactions with US FDA including the development of meeting documents and internal team preparatory activities
- Managing the development of complex regulatory submissions (e.g. IND applications postapproval supplemental applications etc.) through the coordination of multidisciplinary product development teams and ensuring regulatory submissions comply with applicable US FDA regulations and guidance documents including US promotional materials
- Maintaining regulatory expertise and serving as internal consultant on relevant USspecific regulations and guidelines current regulatory environment and regulatory precedent
- Providing authorship and review for a variety of regulatory documents as needed
Skills & Requirements:
Succeeding with our vision of becoming one of the largest pure play vaccine companies in the world is no walk in the park and that is why we need people like you who are determined to make it happen and have the following qualifications:
- Advanced life science degree (MS PhD PharmD) preferred
- 6 years of direct US regulatory affairs experience required experience with biologics preferred
- Experience developing regulatory strategies across all phases of product development
- Proven direct interactions with US FDA and experience with formal meetings with US FDA preferably leading internal preparatory activities and Health Authority interactions
- Experience leading the development of complex regulatory submission in a crossfunctional team environment
Who are you
- We are looking for a team player with a passion for making a difference in a dynamic Global Regulatory Affairs team
- We appreciate that you are flexible with a great sense of accountability and ability to work independently
- We expect that you will effectively liaise with multidisciplinary departments and external partners
- We require excellent written and verbal communication skills
We offer
A chance to work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies. We offer a comprehensive benefits plan and a competitive compensation package.
Salary Range $123k – $180k
Location: US Remote – East Coast Preferred
Caught your interest
If you are interested in the position we look forward to receiving your application via our recruitment system. Just click the ApplyButton on the right side of the page and you will be redirected to our application form.
Founded in 1994 we have 30 years of experience developing lifesaving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains marketleading vaccines against rabies tickborne 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.
Bavarian Nordic
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Employment Type
Full Time
