Associate Director, Regulatory CMC

About Aura:

At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.

We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs’ broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.

Position Summary:

Aura Biosciences, Inc. is currently expanding its Regulatory team to support late-phase clinical assets and is searching for a highly motivated and hands-on Associate Director, Regulatory CM to support the continued development of belzupacap sarotalocan (AU-011) in the treatment of ocular and non-ocular cancers. This individual will be responsible for leading our Small Molecule/Pharmaceutical Regulatory filings.  This position reports to the Sr. Director of Regulatory CMC.

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.
• 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 and GMP 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 lead 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 the development and communication of overall CMC regulatory strategy for internal or partnered programs.
• Assess regulatory impact of GMP changes.
• Provide guidance to internal project teams and CMO/CRO partners to ensure regulatory compliance.
• Engage with health authorities on CMC matters.

Qualifications:

• Bachelors Degree required, Masters or in-field advanced certifcation strongly preferred
• A minimum of 8-10 years working in Regulatory field, in BioTech or related industry
• Strong technical understanding of process and product development
• Development experience with pharmaceuticals required.
• Prior hands-on experience of FDA CMC regulatory submissions is essential with strong knowledge and experience in product development.
• Extensive experience in the preparation and oversight of CMC (Module 3) submissions (i.e., INDs, IMPDs, NDAs, MAAs).
• Demonstrated expertise in Health Authority CMC guidance (FDA, EMA, Health Canada, etc.) and ability to effectively apply the principles in the authoring of Module 3 documents.
• Experience leading or supporting CMC interactions with health authorities.
• Demonstrated ability to influence through effective verbal and written communication.
• 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 organizational, written and verbal communication skills.
• Positive attitude and proactive.
• Strong attention to detail and the ability to multi-task in a fast-paced environment.
• Ability to effectively work individually, within a cross-functional team, as well as with external partners and vendors.