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Associate Director of CMC Regulatory Affairs

4 months ago

West Columbia, United States Aurion Biotech Full time

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Associate Director of CMC Regulatory Affairs

Associate Director of CMC Regulatory Affairs Fully Remote

• US Remote - WA, NM, SD, KS, TX, IN, SC, NC, PA, NY, or MA applicants only Description JOB TITLE: Associate Director of CMC Regulatory Affairs LOCATION:

The role is remote in the USA, but only eligible to residents of the following states: WA, NM, SD, KS, TX, IN, SC, NC, PA, NY, and MA. ABOUT THE POSITION Aurion Biotech is a rapidly growing biotech startup focused on developing innovative cell therapies to treat ocular diseases. We are looking for an Associate Director of CMC Regulatory Affairs. If you are a highly motivated and experienced CMC professional with a passion for developing innovative cell therapies, we encourage you to apply for this exciting opportunity to join our team. KEY RESPONSIBILITES Propose and implement global CMC regulatory strategies and provide regulatory guidance to cross-functional teams and functional areas for assigned programs from the pre-clinical stage through approval and life-cycle management. Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders in a timely manner. Assess and communicate regulatory requirements to ensure all CMC activities are in compliance with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports. Plan, manage, author, review, and obtain stakeholder alignment to facilitate the submission of high-quality CMC sections of regulatory submissions to support initial INDs/CTAs, marketing applications, supplements and variations. Lead multidisciplinary teams preparing responses to Regulatory Agency questions. Effectively plan, organize and contribute to formal meetings with global regulatory agencies to ensure alignment on CMC strategies, resolve CMC issues and oversee proactive interactions for initial INDs/CTAs, marketing registration applications, supplements and variations. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of regulatory applications. Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation. Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global programs. ABOUT AURION BIOTECH With offices in Seattle, Boston and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values: Stewardship : We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company. Transformation : We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. Grit : We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments. Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit www.aurionbiotech.com LIFE AT AURION BIOTECH We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding: Robust Benefits : We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO. Total Rewards:

Everyone is a shareholder at Aurion Biotech. We offer competitive equity grants, salaries, and bonuses. Perks and Fun:

Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values. Requirements

QUALIFICATIONS AND EDUCATION To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. A Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline with 7+ years of experience in a CMC Regulatory function in a pharmaceutical, biotechnology, or related environment required. Experience in cell and gene therapy is desirable. Demonstrated, hands-on experience, managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations. Demonstrated track record of successful global regulatory submissions and strategies. Strong competency in understanding global regulatory requirements and the emerging regulatory landscape. REQUIRED SKILLS AND ABILITIES Ability to travel up to 20% of the time Detail oriented with excellent written and verbal communication and presentation skills. Ability to work independently and collaboratively, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members. Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs.

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