Senior Manager, Regulatory Affairs

🔥 8 minutes ago

🇺🇸 United States – Remote

💵 $139.8k - $184.8k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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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

• Plan and manage regulatory activities for assigned projects spanning clinical, non-clinical, and CMC technical areas • Assist in developing and implementing strategies for earliest possible approvals or clearance of regulatory submissions • Manage preparation, writing, assembly, review, and timely submission of regulatory dossiers for product investigation and registration in the US and abroad • Ensure regulatory submissions remain compliant with regulatory requirements • Support and manage preparation of meeting requests and briefing documents • Manage preparation, review, and submission of INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, and other submission components • Participate on cross-functional project teams and provide regulatory expertise • Develop and maintain current regulatory knowledge and advise management on significant developments • Ensure compliance with departmental requirements and maintain the regulatory archive • Work with external regulatory consultants and CROs as required

🎯 Requirements

• 7+ years’ related experience • BA/BS degree • Experience and knowledge in preparation of INDs (required) • Experience with NDAs (desirable) • Experience preparing 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/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, self-starter comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

🏖️ Benefits

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