Sr. Director, Regulatory Affairs- CMC

1 month ago

Brighton, United States Aura Biosciences Full time
Job DescriptionJob DescriptionSalary:

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 requirements
  • Performs 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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