CMC Regulatory Affairs

Overview

The CMC Regulatory Affairs position holds a crucial role within the organization, overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory affairs for pharmaceutical products. This role is essential in ensuring compliance with global regulations, driving product development and manufacturing activities, and securing regulatory approvals.

Key responsibilities

• Develop and execute CMC regulatory strategies for product development and commercialization.
• Ensure compliance with relevant regulatory requirements and guidelines.
• Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, and variations.
• Lead interactions with health authorities regarding CMC topics.
• Provide CMC regulatory guidance and support to cross-functional teams.
• Conduct risk assessments and develop risk management plans for CMC-related activities.
• Review and approve manufacturing and testing documentation.
• Participate in product development and manufacturing process improvements.
• Contribute to regulatory intelligence activities to stay abreast of changing regulations and guidelines.
• Manage CMC regulatory aspects of post-approval changes and life cycle management.
• Collaborate with external partners and stakeholders on CMC regulatory matters.
• Contribute to the development and maintenance of CMC-related policies and procedures.
• Participate in regulatory agency inspections and audits.
• Provide CMC regulatory support for due diligence activities related to partnerships and acquisitions.
  
  

Required Qualifications

• Bachelor's or advanced degree in a scientific discipline, such as Chemistry, Pharmacy, or related field.
• 5 years of experience in CMC regulatory affairs in the pharmaceutical industry.
• Strong understanding of global regulatory requirements and guidelines related to CMC.
• Proven track record of successful interactions with regulatory agencies.
• Experience in developing and implementing CMC regulatory strategies.
• In-depth knowledge of pharmaceutical product development, manufacturing, and quality systems.
• Excellent project management and organizational skills.
• Strong analytical and problem-solving abilities.
• Ability to communicate effectively and influence stakeholders at all levels.
• Understanding of risk management principles as applied to CMC activities.
• Experience with regulatory submissions, variations, and post-approval changes.
• Collaborative mindset with the ability to work in cross-functional teams.
• Familiarity with regulatory intelligence tools and resources.
• Demonstrated ability to adapt to changing regulatory landscapes and requirements.
• Certification in Regulatory Affairs (e.g., RAC) is a plus.
  
  

Skills: strategic thinking,project management,cmc,cmc regulatory affairs,manufacturing,regulatory affairs