Senior Regulatory Affairs Associate, CMC

Role Overview

• Develop comprehensive CMC strategies for early-stage programs and marketed products
• Author and review regulatory submissions, including:
• Investigational New Drug (IND) applications
• Investigational Medicinal Product Dossiers (IMPDs)
• Post-approval variations/supplements
• Annual reports
• Responses to health authority questions
• Ensure all submissions conform to relevant health authority guidelines and regulations
• Lead submission preparation meetings and coordinate cross-functional input
• Perform regulatory assessments of manufacturing changes
• Establish data requirements for regulatory submissions related to manufacturing changes
• Provide expert guidance on CMC-related regulatory implications of proposed changes
• Represent Regulatory CMC at project team meetings
• Lead submission preparation meetings
• Address reviewer comments and manage regulatory correspondence
• Provide regular updates to Management on project status and key milestones
• Mentor junior team members in Regulatory CMC practices
• Work closely with various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development
• Facilitate effective communication between internal teams and regulatory authorities
• Provide CMC regulatory expertise to support business decisions and product development strategies
• Stay current with evolving CMC regulations, guidelines, and industry best practices
• Contribute to the development and implementation of internal CMC regulatory policies and procedures
• Participate in relevant industry groups and regulatory authority meetings as needed

Requirements

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field (Ph.D. preferred)
• Minimum of 8+ years of experience in Regulatory Affairs, with a strong focus on CMC
• Extensive knowledge of global CMC regulatory requirements and submission processes
• Proven track record of successful regulatory submissions and interactions with health authorities
• Strong understanding of pharmaceutical development, manufacturing processes, and quality systems
• Experience with both small molecules and biologics is highly desirable
• Excellent project management skills with the ability to manage multiple projects simultaneously
• Strong analytical and problem-solving skills
• Outstanding written and verbal communication skills

Benefits

• Professional development opportunities
• Flexible working hours