Senior Associate, US Regulatory Affairs

🔥 13 hours ago

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BeOne Medicines

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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

• Manage, evaluate, and complete regulatory projects consistent with company goals • Plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions • Manage the preparation, writing, assembly, review, and timely submission of regulatory dossiers • Ensure regulatory submissions are maintained in compliance with regulatory requirements • Support and manage preparation of meeting requests and briefing documents • Manage the preparation, review, and submission of all components of regulatory submissions • Participate on project teams and provide expertise on regulatory matters • Develop and maintain current regulatory knowledge and advise management of significant developments • Prepare and maintain regulatory archive • Work with external regulatory consultants/CRO’s as required

🎯 Requirements

• BA / BS in Health Science, preferred, with at least 2+ years ’ experience in the pharmaceutical industry • Experience and knowledge in preparation of INDs (required) and NDAs (desirable) • Experience with CTD/eCTD • Experience with publishing documents in Adobe Acrobat Professional • Working knowledge of FDA and ICH regulatory guidance and regulations • Understanding of FDA structure and function • Knowledge/experience with regulatory requirements for other regions also desirable • Working knowledge of GMP, GLP, and GCP regulations • Excellent oral and written communications skills • The candidate should be detail-oriented, a self-starter, and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

🏖️ Benefits

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