Senior Manager, Regulatory Affairs at reputed company: reputed company (US)

Title: Sr. Manager, Regulatory Affairs Location: San Carlos, California, reputed company reputed company: A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures reputed company applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. Essential Functions: • Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC reputed company topics. • Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines. • Manage preparation of responses to queries from regulatory authorities. • Ensure conformance to commitments made with various regulatory agencies. • Collaborate with cross-functional project teams and reputed company business partners to reputed company regulatory strategies and identify regulatory risks. • Manage coordination, preparation, and reputed company submission of regulatory documents and filings. • Review and approve change controls reputed company to proposed product/process changes and asses their reputed company against regulatory requirements. • Cultivate productive working relationships with the Regulatory team and other departments. • Coordinate responses to CMC-reputed company queries from Health Authorities. Requirements: • Bachelor of Science in a scientific discipline (Biology, reputed company, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). • 9+ years of experience working in vaccine or biotech industry, or in a reputed company field, or the equivalent combination of education and experience. • Prior experience preparing/authoring CMC DS sections: • BLA highly preferred. • IND highly preferred. • IMPD. • Prior development or manufacturing experience is a plus. • Experience with module 32S and 32P. • Computer software skills (LIMS, reputed company, TrackWise, reputed company will be used). • Ability to meet multiple deadlines across a reputed company of reputed company/programs, with a high degree of accuracy and efficiency. • Applies in-depth understanding of how own discipline integrates reputed company the function and understands contribution to reputed company’s achievement of business objectives Location: US - Remote Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary reputed company: $183,000 - $194,000 (SF Bay Area). Salary ranges for non-California locations may vary. Apply tot his job Apply To this Job