Manager-Director, Regulatory
2 months ago
Responsible for providing support in Regulatory Operations filing multiple original INDs each year and managing multiple active INDs in Phase 1/2 clinical trials (US, Canada, EU and APAC). He/she will manage day to day regulatory operations to ensure all Kumquat regulatory submissions are on time, complete, and comply with applicable regulatory requirements, support completion of IND Annual Reports, IND Safety Reports and various types of amendments.
The position will also include aspects of eCTD publishing and formatting documents/reports per regulations for eCTDs and has hands-on experience using eCTD submission software. He/she will also assume responsibility for the tracking and filing of a large number of regulatory documents for archiving purposes.
The person will also contribute to Kumquat cross-functional project teams by translating regulatory requirements into practical, workable plans and providing strategic guidance on projects and submission document content. The right person will have the opportunity to play a dynamic leadership role in a small company environment including interaction with FDA and senior management from all functional areas of the company.
Essential Job Responsibilities:
· File multiple original INDs per year for new Kumquat product candidates.
· Manage multiple active INDs/CTAs in Phase 1/2 trials concurrently, complete and track various types of amendments, IND Safety Reports, IND Annual Reports/DSURs, and responses to information requests from global Regulatory Agencies. Control and maintain regulatory submission logs and files in a secure and organized manner.
· Ensure regulatory submissions are completed on time by working with project teams to gather the information and documents necessary to file complete and accurate submissions in accordance with corporate goals.
· Responsible for the preparation, submission, distribution and archiving of all regulatory submissions, including original INDs, amendments, safety reporting and follow-ups, annual reports and ongoing application maintenance.
· Assist in preparation of IND/CTR documents in eCTD format for original and multiple active INDs, including formatting, publishing, and organizing files in an eCTD compliant manner. Maintain templates which meet Kumquat and regulatory CTD submission standards and suggest updates as necessary.
· Interact with regulatory agencies.
· Provide support to QA, pre-Clinical and Clinical, CMC and other project stakeholders in maintenance of active INDs and Kumquat policies and procedures.
· Stay abreast of evolving regulatory requirements in the US and other ICH regions.
· Conduct regulatory intelligence/research related to Kumquat products and assist in formulation of strategic regulatory decisions.
· Contribute and implement departmental policies and procedures. Establish and support a work environment of continuous improvement.
Requirements:Below requirements are minimum for a manager position in Regulatory.
· Bachelor’s degree, graduate level education a plus.
· Experience working in oncology desirable.
· Prior hands-on experience in IND submission via eCTD submission software.
· Working knowledge with US drug regulations as well as ICH and US guidance documents.
· General understanding of pre-IND to Phase 2 regulatory submissions for investigational new drugs and FDA expedited approval programs for serious conditions.
· Ability to manage multiple projects/submissions concurrently a must.
· Strong oral and written communication, technical writing, editing, formatting, and publishing skills are required.
· Excellent organizational skills with attention to detail.
· Strong leadership, interpersonal skills and the ability to work in a project team environment.
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