Senior Manager, Global Regulatory Affairs -CMC

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 risk-takers. 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. Hard-won 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 up-to-date 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.

Required Knowledge, Skills, and Abilities

• Background in vaccine development with knowledge of the vaccine drug product development process 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.

Education, Experience, Licenses & Certifications

• Bachelor's degree preferably in a scientific field. An advanced degree is desirable.

• A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.

The annual base salary (or hourly wage) for this position falls within the range of $109,900.00 - $142,900.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will 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.