Senior Regulatory Manager

Job DetailExperience Level Sr ManagerDegree Type Bachelor of Science (BS)Employment Full TimeWorking Type On SiteJob Reference 0000019399Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful regulatory projects at a dynamic organization with global reach. Collaborate across departments, including the CEO, for strategic decision-making. Enhance your expertise in regulatory affairs and CMC compliance.Job DescriptionOverviewLead regulatory strategy development and implementation for pharmaceutical products in development and post-approval stages.Coordinate and manage scientific and regulatory submissions, including INDs, NDAs/BLAs, IMPDs, and MAAs.Serve as the scientific representative on project teams, contributing to strategic decision-making.Provide regulatory support for analytical method development, validation activities, and stability programs.Ensure compliance with changing regulations and health authority actions.Collaborate with global offices and teams to ensure regulatory alignment and effectiveness.Work closely with manufacturing and QA/QC teams to evaluate regulatory impacts of proposed changes.Contribute to lifecycle management of regulatory dossiers and submissions.Key Responsibilities & DutiesManage planning, preparation, and submission of regulatory dossiers in compliance with global standards.Evaluate regulatory impacts of manufacturing, analytical, and quality changes.Act as the primary liaison with health authorities for assigned products.Draft and coordinate Chemistry, Manufacturing, and Controls (CMC) sections within eCTD format.Provide scientific and regulatory support for method development and validation activities.Collaborate with global CMOs and CROs to ensure regulatory compliance.Monitor and adapt to changing regulatory requirements and health authority actions.Support GLP and GMP compliance, including on-site inspections.Job RequirementsBachelor of Science (BS) in Chemistry, Biotechnology, or related field; advanced degree preferred.Minimum 7 years of experience in regulatory affairs, with 8 years preferred.Proven expertise in CMC regulatory strategy and eCTD authoring.Experience with FDA, EMA, and Health Canada regulatory requirements.Knowledge of GLP and GMP compliance, including prior inspection experience.Ability to interpret scientific data and technical instructions effectively.Experience working with global CMOs and CROs.Familiarity with Veeva systems is a plus.