Regulatory Affairs – CMC

Summary 

The Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs professional plays a crucial role in ensuring that pharmaceutical products meet the necessary regulatory standards and are safe, effective, and of high quality. Their expertise contributes to the development and approval of pharmaceutical products. 

Responsibilities: 

• Develop and execute regulatory strategies for Chemistry, Manufacturing, and Controls aspects of drug development and commercialization. 
• Prepare and submit regulatory documents and applications for global regulatory submissions, including INDs, NDAs, MAAs, and variations/supplements. 
• Review and assess manufacturing and quality control documentation, such as batch records, stability data, analytical methods, and specifications, to ensure compliance with regulatory requirements and industry standards. 
• Communicate with other departments to ensure regulatory compliance throughout the manufacturing process. 
• Prepare for inspections and audits and present any identified deficiencies. 
• Present and provide guidance to internal teams and external stakeholders, while also maintaining proper documentation of regulatory files and submission records. 

Qualifications 

• Bachelor's or advanced degree in a scientific discipline (e.g., chemistry, pharmacy, pharmaceutical sciences, or related field). 
• Proficient knowledge and understanding of regulatory requirements and guidelines related to CMC in the pharmaceutical industry. 
• Experience in regulatory affairs with a focus on CMC activities, including regulatory submissions and compliance. 
• Familiarity with global regulations and guidelines from regulatory authorities such as the FDA, EMA, and ICH. 
• Strong understanding of manufacturing processes, quality control, and analytical techniques relevant to pharmaceutical products. 
• Excellent written and verbal communication skills. 
• Strong analytical and problem-solving abilities. 
• Ability to work both independently and collaboratively in a team environment. 
• Ability to manage multiple priorities, meet deadlines, and adapt to changing requirements.