Senior Manager Regulatory Affairs

Job DetailExperience Level Sr ManagerDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type HybridJob Reference 0000021038Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful regulatory strategies in a dynamic pharmaceutical environment. Collaborate globally and grow professionally within a small, agile company. Drive compliance and innovation in a hybrid work setting.Job DescriptionSenior Manager Regulatory Affairs OverviewThe Senior Manager Regulatory Affairs will lead regulatory strategies for pharmaceutical products in development and post-approval stages.This hybrid role offers the opportunity to collaborate closely with global offices and cross-functional teams.Work within a dynamic, small company environment with significant growth opportunities and direct interaction with leadership.Contribute to the preparation and submission of regulatory dossiers, ensuring compliance with international standards.Engage in strategic decision-making processes, evaluating regulatory impacts of manufacturing and analytical changes.Serve as a scientific representative on project teams, providing expertise in regulatory affairs and CMC processes.Stay updated on evolving regulations and health authority actions, ensuring organizational readiness.Collaborate with global CMOs and CROs, ensuring effective regulatory compliance and product development.Support analytical method development, validation activities, and stability programs for pharmaceutical products.Senior Manager Regulatory Affairs Key Responsibilities & DutiesPlan, prepare, and submit regulatory dossiers including INDs, NDAs/BLAs, IMPDs, and MAAs.Evaluate the regulatory impact of proposed manufacturing, analytical, or quality changes.Act as the primary liaison with Health Authorities for assigned products.Provide scientific and regulatory support for analytical and bioanalytical method development and validation activities.Draft and manage Chemistry, Manufacturing, and Controls (CMC) sections within eCTD format.Interpret scientific data and technical instructions to identify problems and establish facts.Collaborate with global offices in Italy and Switzerland to ensure regulatory compliance.Support pharmaceutical product development and lifecycle management activities.Maintain knowledge of GLP and GMP compliance, supporting on-site inspections as needed.Senior Manager Regulatory Affairs Job RequirementsPhD in Chemistry or a related field with 7-8 years of regulatory experience.Extensive experience in CMC regulatory affairs, including eCTD authoring and submission management.Knowledge of FDA, EMA, and Health Canada regulatory requirements for various dosage forms.Experience in manufacturing, QA/QC, and pharmaceutical product development.Proficiency in regulatory evaluation of manufacturing changes and global compliance.Ability to interpret scientific data and technical instructions effectively.Familiarity with Veeva systems is a plus but not required.Strong communication skills, with the ability to liaise with Health Authorities and global teams.Willingness to travel occasionally for regulatory and compliance purposes.