Senior Manager Global Regulatory Affairs -CMC
Senior Manager Global Regulatory Affairs -CMC
Posted on :
24-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
24-01-2025
Job Description
Job Title: Senior Manager Global Regulatory Affairs CMC
Job Location: Maryland USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
If you find science speed and helping address serious infectious diseases exhilarating you have come to the right place.
Individually we’re skilled driven and confident risktakers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences cultures and learnings to turn innovation into reality while maintaining the highest standards. We value balance encourage growth and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!
Novavax Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases and we are here to make a difference. Hardwon lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research has tremendous potential to make a substantial contribution to public health worldwide.
Job Summary (Describe the purpose and overall objective of the role. Include description of nature of interactions with other roles or customers.)
Novavax Regulatory Affairs team is hiring a Sr. Manager CMC to lead and support key regulatory CMC activities.
Essential Functions
Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an atwill basis regardless of their race color national origin religion ancestry citizenship status military or veteran status sex sexual orientation gender identity or expression age marital status family responsibilities pregnancy disability genetic information protective hairstyle or any other characteristic protected by applicable federal state or local law.
Individually we’re skilled driven and confident risktakers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences cultures and learnings to turn innovation into reality while maintaining the highest standards. We value balance encourage growth and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!
Novavax Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases and we are here to make a difference. Hardwon lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research has tremendous potential to make a substantial contribution to public health worldwide.
Job Summary (Describe the purpose and overall objective of the role. Include description of nature of interactions with other roles or customers.)
Novavax Regulatory Affairs team is hiring a Sr. Manager CMC to lead and support key regulatory CMC activities.
Essential Functions
- Assist with CMC regulatory submission strategies.
- Manage key regulatory CMC activities including planning writing and reviewing of documents necessary to support regulatory submissions including INDs IMPDs CTAs BLAs MAAs meeting requests briefing packages and responses to queries from regulatory agencies.
- Ensure that overall project timelines support the coordination and preparation of timely submissions.
- Communicate and coordinate with relevant functional groups and project team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions.
- Act as regulatory CMC representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
- Maintain uptodate working knowledge on relevant regulations guidance and the current regulatory environment. Provide updated information on regulatory CMC issues to project teams and other personnel.
- Establish regulatory CMC processes and procedures and provide training to other departments.
- Background in vaccine development with knowledge of the vaccine drug product development process with the emphasis on influenza vaccines is highly desirable.
- Experience with aseptically filled drug products.
- Good understanding and experience with current GMPs and regulatory expectations for investigational and marketed products.
- Experience with CTD format and content.
- Ability to work independently and within a group setting and to interact effectively with different functional departments.
- Strong communication skills (oral written and interpersonal) and the ability to identify and recommend solutions to problems.
- Bachelor's degree preferably in a scientific field. An advanced degree is desirable.
- A minimum of 610 years in the biotechnology industry with 45 years in Regulatory Affairs CMC.
Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an atwill basis regardless of their race color national origin religion ancestry citizenship status military or veteran status sex sexual orientation gender identity or expression age marital status family responsibilities pregnancy disability genetic information protective hairstyle or any other characteristic protected by applicable federal state or local law.
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Employment Type
Full Time
Key Skills
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