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

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

Senior Associate, US Regulatory Affairs

Key skills