Associate Director, Regulatory CMC

About Aura:

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.

For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Position Summary:

Aura Biosciences is currently expanding its Regulatory team to support early- and late-phase clinical assets and is searching for a highly motivated and hands-on Associate 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 team and will be responsible for supporting the development of CMC regulatory strategies and managing high-quality submissions to global regulatory agencies. This position reports to the Sr Director, Regulatory CMC and will support further growth of the Regulatory Affairs function.

Responsibilities:

Responsible and accountable for authoring, review, and managing preparation of submission-ready CMC documents, including clinical trial and marketing applications, formal meeting requests and briefing documents, and commercial life-cycle management submission.

• The Associate Director will be responsible for clinical and commercial submissions including, authoring, adjudicating/addressing the review and QC comments, and finalizing the submission documents.


• Author, review and approve CMC technical documentation for the Regulatory CMC function.


• Responsible for the overall CMC submission development, including planning, authoring, reviewing, and editing as required to meet cross-functional team objectives and timelines.


• The successful candidate will support the CMC regulatory strategy to support global development and lifecycle.


• This role is accountable for compliance with evolving Quality/CMC regulations and guidelines to support early development, registration, and lifecycle management.


• Serves as Regulatory CMC lead for all assigned program(s), including supporting the development and communication of overall CMC regulatory strategy for internal or partnered programs.


• Assess regulatory impact of CMC functional changes.


• Provide guidance to internal project teams and CDMO/CRO partners to ensure regulatory compliance.


• Engage with health authorities on CMC matters.

Qualifications:

A Bachelor, MS or Ph.D degree in Pharmacy, Biology, Chemistry, Pharmacology or an industry-related field with at least 5 years of Regulatory CMC experience in pharmaceutical or biotech company. Large molecule drug development experience is preferred.

• Strong technical understanding of process and product development


• Hands-on experience in the preparation and oversight of CMC (Module 3) submissions (i.e., INDs, IMPDs, BLAs, NDAs, MAAs).


• Demonstrated expertise in Health Authority CMC guidance (ICH, FDA, EMA, Health Canada, etc.) and ability to effectively apply the principles and assess the regulatory implication for the functional CMC activities and the authoring of Regulatory CMC documents.


• Ability to understand the differences in the CMC regulations among small molecules, biologics and drug conjugates, and the shared regulations among the different drug modalities.


• Experience leading or supporting CMC meetings and pilot programs with health authorities.


• Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously with accuracy.


• Proven ability to independently manage multiple projects, to proactively identify and resolve regulatory issues, to appropriately raise issues to management, and to bring an insightful approach to problem solving.


• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.


• Adept at communicating a clear vision among team members effectively aligning resources to achieve functional area goals.


• Hands-on experience for regulatory information management systems.

Salary & Benefit Information:

Salary Range: $160,000/yr - $210,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance