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Avidity NanoMedicines
San Diego, CA, United States
Description Job Title: Director, Regulatory Operations Location: Hybrid / Remote Position type: FLSA: Full time Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by del
Job Source: Avidity NanoMedicinesAvidity NanoMedicines
San Diego, CA, United States
Job Title: Director, Regulatory Operations Location: Hybrid / Remote Position type: FLSA: Full time Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of
Job Source: Avidity NanoMedicinesBioSpace, Inc.
San Diego, CA, United States
Job Title: Director, Regulatory Operations Location: Hybrid / Remote Position type: FLSA: Full time Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of
Job Source: BioSpace, Inc.Cypress HCM
San Diego, CA, United States
The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and
Job Source: Cypress HCMCharles River Laboratories
San Diego
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your ski
Job Source: Charles River LaboratoriesKumquat Biosciences Inc
San Diego, CA, United States
Job Description Job Description Description: 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, compl
Job Source: Kumquat Biosciences IncCypress HCM
San Diego, CA, United States
The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and
Job Source: Cypress HCMPartnology
San Diego, CA, United States
An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities ess
Job Source: PartnologySan Diego, CA, United States
Job Description :
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 company 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 company 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 company 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 company 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 company policies and procedures.
Stay abreast of evolving regulatory requirements in the US and other ICH regions.
Conduct regulatory intelligence/research related to company 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 the minimum to be considered for the role.
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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Email Alert for AD/Director, Regulatory Operations jobs in San Diego, CA, United States
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