Aura Biosciences
Sr. Director, Regulatory Affairs- CMC
Aura Biosciences, Boston, Massachusetts, us, 02298
ABOUT AURA:
Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.
We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas – ocular oncology and bladder cancer – with a goal to expand into other areas of solid tumor oncology. Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved. We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma. We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial.
We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions. AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.
Position Summary:Aura Biosciences is currently expanding its Regulatory team to support late-phase clinical assets and is searching for a highly motivated and hands-on Sr. Director, Regulatory Affairs-CMC to support the continued development of AU-011 in the treatment of ocular and urologic cancers. This individual will operate in a high-visibility role and will be responsible for developing CMC regulatory strategies and managing high-quality submissions to global regulatory agencies. This position reports to the SVP, Regulatory Affairs and Quality and will drive further growth of the Regulatory Affairs function.
Responsibilities:
Design well-informed global regulatory strategies from a CMC perspective
Represent Regulatory Affairs on AU-011 program teams and subteams providing solid regulatory strategy guidance (e.g., , CMC modules in regulatory filings, report reviews, development plans) to support efficient drug development
Lead the coordination, preparation, and timely submission of regulatory documents (e.g., INDs, CTAs, BLAs, NDAs, MAAs).
Write regulatory documents (CMC focused) to support regulatory agency submissions
Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies; archive submissions and maintain submissions logs
Builds and maintains excellent relationships with regulatory authorities, while serving as primary contact with FDA on the AU-011 program
Leads the preparation for regulatory agency meetings (e.g., Type C, Pre-BLA/MAA/BLA)
Establish relevant processes and procedures to support the Regulatory Affairs function activities
Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
Ensure compliance with regulatory requirementsPerforms other duties as assigned
Qualifications:
Bachelor's degree in life sciences required; advanced degree preferred
Biologics experience preferred
Oncology and/or ophthalmology experience preferred
Experience in 510(k) and/or PMA submissions desirable
Minimum of 10 years pharmaceutical industry experience with a minimum of 8 years in Regulatory Affairs (CMC)
Evidence of successful submissions to FDA and EMA (e.g., IND, NDA, BLA, MAA, briefing packages)
Leading preparation of an NDA/BLA and MAA preferred
Demonstrated evidence of writing regulatory documents (Module 1, Module 2, briefing packages)
Knowledge of global regulatory requirements desirable
Knowledge of drug development
Ability to motivate and develop direct reports
Ability to multitask and work on several projects at once.
Excellent written and oral communication skills
Excellent interpersonal skills
Strong project management skills and drive for excellence
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Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.
We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas – ocular oncology and bladder cancer – with a goal to expand into other areas of solid tumor oncology. Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved. We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma. We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial.
We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions. AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.
Position Summary:Aura Biosciences is currently expanding its Regulatory team to support late-phase clinical assets and is searching for a highly motivated and hands-on Sr. Director, Regulatory Affairs-CMC to support the continued development of AU-011 in the treatment of ocular and urologic cancers. This individual will operate in a high-visibility role and will be responsible for developing CMC regulatory strategies and managing high-quality submissions to global regulatory agencies. This position reports to the SVP, Regulatory Affairs and Quality and will drive further growth of the Regulatory Affairs function.
Responsibilities:
Design well-informed global regulatory strategies from a CMC perspective
Represent Regulatory Affairs on AU-011 program teams and subteams providing solid regulatory strategy guidance (e.g., , CMC modules in regulatory filings, report reviews, development plans) to support efficient drug development
Lead the coordination, preparation, and timely submission of regulatory documents (e.g., INDs, CTAs, BLAs, NDAs, MAAs).
Write regulatory documents (CMC focused) to support regulatory agency submissions
Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies; archive submissions and maintain submissions logs
Builds and maintains excellent relationships with regulatory authorities, while serving as primary contact with FDA on the AU-011 program
Leads the preparation for regulatory agency meetings (e.g., Type C, Pre-BLA/MAA/BLA)
Establish relevant processes and procedures to support the Regulatory Affairs function activities
Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
Ensure compliance with regulatory requirementsPerforms other duties as assigned
Qualifications:
Bachelor's degree in life sciences required; advanced degree preferred
Biologics experience preferred
Oncology and/or ophthalmology experience preferred
Experience in 510(k) and/or PMA submissions desirable
Minimum of 10 years pharmaceutical industry experience with a minimum of 8 years in Regulatory Affairs (CMC)
Evidence of successful submissions to FDA and EMA (e.g., IND, NDA, BLA, MAA, briefing packages)
Leading preparation of an NDA/BLA and MAA preferred
Demonstrated evidence of writing regulatory documents (Module 1, Module 2, briefing packages)
Knowledge of global regulatory requirements desirable
Knowledge of drug development
Ability to motivate and develop direct reports
Ability to multitask and work on several projects at once.
Excellent written and oral communication skills
Excellent interpersonal skills
Strong project management skills and drive for excellence
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