Associate Director, Regulatory Affairs, CMC

🕒 February 14

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Serve as the regulatory CMC representative on project teams. • Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, Supply Chain and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers. • Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. • Author and lead CMC content for Health Authority meeting briefing packages, including development of CMC strategy, preparation of CMC-related questions, supporting data summaries, and responses to Health Authority feedback, in collaboration with Global Regulatory and cross-functional teams. • Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product. • Actively participate as a member of global regulatory teams and CMC subteams. • Support and manages regulatory aspects of CMC Operations including authoring, reviewing and or approving SOP’s, CAPA’s, etc.

🎯 Requirements

• Minimum 8+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and commercial product lifecycle including Phase 1-3, and marketed products) • BS/BA Biochemistry, Biology, or Pharmaceutical Science; Advanced degree preferred. • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), Veeva Data Management System • Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues. • Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities. • Demonstrated ability to coach, train and mentor teams. • Strong negotiating skills and ability to think creatively and develop creative solutions.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness