Sr. Associate, Regulatory Affairs
San Rafael, CA
Who We Are From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. SummaryThe Senior Associate supports Regulatory leadership in the development and execution of global nonclinical / clinical regulatory strategies through a program\u2019s lifecycle.\u00A0 The Senior Associate will typically support the efforts to preparation for HA interactions and complete regulatory submissions.\u00A0 The Senior Associate may take on a leadership role for selected submission activities depending upon the product lifecycle. (development or commercial).\u00A0 Responsibilities The RNC Senior Associate responsibilities may vary depending upon product regulatory lifecycle and may include the support of selected activities which will be delegated by the Regulatory Nonclinical/ Clinical leadership and may include the following:\u00A0Development Stage Product Support the development of the nonclinical / clinical regulatory strategy and plan. Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions. Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead. Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials. With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions. Responsible for ensuring high quality nonclin/clinical content that adheres to regulations and guidances. Support the maintenance of IND/CTAs throughout the life of the studies Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books,, etc.) and completing regulatory documents/forms for internal review. Collaborate with Reg PM to create and align submission timelines, Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA. Collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA. Organize and maintain the administrative, nonclinical, and clinical portions of IND\u2019s, NDA\u2019s and BLA\u2019s. Coordinate the archiving of HA submissions and correspondenceCommercial Stage Product Support the development of updates to the clinical and nonclinical sections of the core dossier used for INTL marketing applications. Support the development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings. Coordinate necessary interactions with INTL in support of INTL MA filings. Example include: meetings to provide RNC guidance/input on agency interaction, submissions, RTQs.General Attend relevant functional area and project team meetings. Review, understand and stay up to date on regulations, guidelines relevant to responsibilities Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary Ensure that the PM timelines and tracker accurately reflect submission plans\u00A0Education & Experience Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience 2 year experience with PhD; 4 years with Masters, 6 with bachelor\u2019s degrees Nonclinical / Clinical Regulatory Affairs experience preferred PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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