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
Develop and maintain current regulatory knowledge and advise management of significant developments. Ensure compliance with departmental requirements including maintenance of regulatory archive. Work with external regulatory consultants/CROs as required.

Requirements

7+ years’ related 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 well as 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.

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

IND preparationNDA preparationCTDeCTDregulatory submissionsregulatory dossiersGMPGLPGCPregulatory compliance

Soft Skills

oral communicationwritten communicationplanningdetail-orientedself-starterentrepreneurial mindsetability to manage broad responsibilitiesteam collaborationproblem-solvingadaptability