Regulatory Affairs Associate
|Location||Los Angeles, CA|
Our growing biotechnology client in Los Angeles has experienced tremendous success with their oncology drugs and needs a Senior Associate, Regulatory Affairs on a long-term contract. The Senior Associate will support, and coordinate efforts associated with the preparation of regulatory documents or submissions with Global Regulatory Leads (RGLs), Regional Regulatory Leads (RRLs) and CMC Regulatory Lead.
- Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
- Provide primary authorship to routine regulatory correspondence to maintain IND, IMPD, CTA, NDA and MAAs (including submission TOC, AR, PSUR, PADER, PBRER, DSUR, CCDS, labeling, and IB)
- Create cover letter and forms for applicable submissions
- Complete CTA Questionnaires for all studies on monthly basis
- Create and maintain product regulatory history documents through EDMS and appropriately archive all regulatory documents and agency communications
- Assist the CMC Regulatory Lead, and the Global or Regional Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to worldwide regulatory agency questions.
- Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies including updates to standard operating procedures, work instructions, or policies
- Participate in global regulatory team (GRT), study team, and ad hoc meetings as a regulatory affairs representative
- Assist GRT meeting management (eg, agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes
- Assist CMC Regulatory Lead with the tracking and finalization of the environmental studies for EU
- Support the development and execution of department goals
- Maintain current knowledge of and interpret new regulations, standards, or guidance documents or updates to them
- Coordinate with regulatory publishing and functional team members internally/ externally on applicable submission documents including the drafting, uploading, and routing of documents in EDMS and the review of documents
- Build and maintain spreadsheets that will calculate and organize business metrics as required.
- Other duties as assigned.
Please follow the link below to submit your application for Regulatory Affairs Associate.