Regulatory Affairs Specialist

Our client, a growing biopharma company, is seeking a Regulatory Affairs Specialist to support regulatory strategy and submission activities as the company advances its pipeline through clinical development. Key ResponsibilitiesSupport preparation, compilation, and submission of regulatory documents (INDs, amendments, annual reports, briefing packages) to FDA and/or other health authoritiesTrack and maintain regulatory submission timelines and correspondence logsCoordinate cross-functional input (clinical, CMC, nonclinical, quality) for submission-ready documentsMonitor changes in regulatory guidance and assess impact on ongoing programsSupport preparation for regulatory agency meetings, including briefing document developmentMaintain regulatory files and ensure inspection/audit readinessAssist with labeling review and other regulatory deliverables as programs progressQualificationsBachelor's degree in life sciences, regulatory affairs, or related field; RAC certification a plus3+ years of regulatory affairs experience in pharma or biotech, with hands-on submission experienceWorking knowledge of FDA regulations and ICH guidelines; global submission experience a plusStrong writing, organizational, and project management skillsExperience using regulatory information management (RIM) systems and eCTD publishing tools a plusComfortable working independently and adapting to shifting priorities in a smaller, fast-moving organization Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.