Novavax, Inc. seeks a Manager, Regulatory Affairs CMC in Gaithersburg, MD.
Duties:
• Assist with CMC regulatory submission strategies pertaining to the Drug Substance.
• 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.
• Manage and track completion of source documents and eCTD sections.
• Review Change Controls and provide regulatory assessment/guidance to the Operations/Global Regulatory CMC team(s).
• Facilitate communication and coordination with Global Project Management for key CMC Regulatory deliverables.
• Ensure that overall regulatory project timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory 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.
• Maintain up-to-date working knowledge on relevant regulations, guidance, and the current regulatory environment.
• Act as regulatory CMC representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
• Establish regulatory CMC processes and procedures and provide training to other departments.
100% Telecommuting permitted within the U.S.
$161,075–$196,950 per year. Additional benefits include: annual bonus, equity grants, professional career development/growth opportunities, and medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
To apply: Visit https://www.jobpostingtoday.com/application/17838/apply
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