Senior Manager, Regulatory Affairs

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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 the 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 coordinate regulatory submissions and provide guidance on regulatory strategy and tactics • Represent Regulatory Affairs on cross-functional project teams • Provide regulatory input to project teams • Lead authoring and preparation of annual reporting • Manage regulatory submissions across clinical, non-clinical, and CMC technical areas • Develop and implement strategies for early approval or clearance of regulatory submissions • Prepare, write, assemble, review, and submit regulatory dossiers for product investigation and registration in the US and abroad • Maintain regulatory submissions in compliance with regulatory requirements • Prepare, review, and submit meeting requests and briefing documents • Prepare, review, and submit INDs, amendments, BLAs/NDAs, supplements, annual reports, and safety reports • Participate on project teams and provide regulatory expertise • Maintain current regulatory knowledge and advise management of significant developments • Ensure compliance with departmental requirements and maintain the regulatory archive • Work with external regulatory consultants and CROs as required

🎯 Requirements

• 7+ years of related experience with a BA/BS degree required • Experience and knowledge preparing INDs required • Experience preparing NDAs desirable • Experience with supportive amendments and supplements covering manufacturing, nonclinical, and clinical areas • Experience with CTD/eCTD • Experience publishing documents in Adobe Acrobat Professional • Working knowledge of FDA and ICH regulatory guidance and regulations • Understanding of FDA structure and function • Knowledge or experience with regulatory requirements for other regions desirable • Working knowledge of GMP, GLP, and GCP regulations • Understanding of the pharmaceutical product life cycle • Excellent oral and written communication skills • Superior planning skills • Detail-oriented and self-starting • Comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

🏖️ Benefits

• Annual bonus plan eligibility for Non-Commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness program