22 days ago
BA/BS degree preferred, and / or equivalent experience in a health science field, pharmaceutical experience preferred.
Essential Functions of the job:
• With minimal supervision, 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 associated with assigned projects.
• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
• 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 including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters.
Skills and Experience:
• Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical).
• 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 as well an understanding of the pharmaceutical product life cycle.
• Excellent oral and written communications skills are a must as are superior planning skills.
• The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.