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Associate Director of Regulatory Affairs
Associate Director of Regulatory AffairsFully Remote
US Remote - WA, NM, SD, KS, TX, IN, SC, NC, PA, NY, or MA applicants onlyFull-timeDescriptionJOB TITLE: Associate Director of Regulatory AffairsLOCATION:
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 POSITIONThis role will be important in shaping regulatory strategies, ensuring adherence to guidelines, and facilitating successful product approvals. This individual will oversee regulatory matters for assigned projects, focusing on non-clinical and clinical aspects of drug development. They will support efforts related to regulatory submissions and compliance.KEY RESPONSIBILITIESRegulatory Submissions:Clinical and non-clinical content are well positioned in submissionsOversee any CRO/vendors that are contracted to perform regulatory activities related to clinical and nonclinical regulatory submissions and activitiesLead planning and preparation of core clinical and nonclinical content for global clinical trial applications by collaborating with SMEsMaintain IND/CTAsRegulatory Strategy Development:Lead the development, integration, execution and maintenance of the global non-clinical and clinical regulatory strategyProvide strategic insight and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriateEnsure that Health Authority feedback is incorporated into the global nonclinical and clinical development strategyClinical and Nonclinical:Ensure Clinical and Non-clinical incorporate consideration of current global health authority precedents and regulatory guidance.Provide strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studiesContribute critically to the scientific interpretation and integration of clinical and nonclinical study results.Review and provide comments on all company- sponsored abstracts, manuscripts and publications of original research and press-releases, as requested.Health Authority Meetings:Support planning and preparation of the clinical and non-clinical strategy and content for global HA meetings, working closely with SMEsDeliverables include core content for the briefing book and presentationEnsure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs
ABOUT AURION BIOTECHWith 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.comLIFE AT AURION BIOTECHWe 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 EDUCATIONTo 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 discipline7-10 years of experience in regulatory affairs with direct clinical and non-clinical strategy and submission experienceExperience with understanding and interpreting US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.Experience with managing Regulatory and Publishing CROsExperience in cell and gene therapy is desirableREQUIRED SKILLS AND ABILITIESTravel up to 40% of the time - expected to be closer to 25% on average, but some months may be heavier with travel and flexibility will be necessaryAttention to detail with ability to coordinate and prioritize assigned projects according to company goalsStrong interpersonal skills, both written and verballyAbility to successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas, assuring compliance with regulations and with project team timelines.Provide interpersonal support and lead personnel.Excellent verbal and written communication skills
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