Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs Overview

• The 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 & Duties

• Plan, 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 Requirements

• PhD 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.