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Senior Associate, US Regulatory Affairs
Location
United States
Posted
10 days ago
Salary
$93.6K - $123.6K / year
Seniority
Senior
Job Description
Senior Associate, US Regulatory Affairs
BeOne Medicines
• 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
Job 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
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