Executive/ Senior Executive - 21 CFR

Regulatory Compliance

• Ensure full compliance with applicable 21 CFR regulations (including but not limited to 21 CFR Part 210, 211, 312, 314, 820 as applicable).
  
• Interpret and implement FDA regulatory requirements across manufacturing, quality, and development functions.
  
• Monitor changes in FDA regulations and assess impact on company processes.
  

Documentation & Submissions

• Review, prepare, and maintain regulatory documents such as SOPs, validation protocols, batch records, and quality manuals.
  
• Support preparation and review of IND, NDA, ANDA, DMF, or 510(k) documentation as applicable.
  
• Ensure data integrity and document control in line with 21 CFR Part 11 requirements.
  

Quality Systems & Audits

• Support implementation and maintenance of Quality Management Systems (QMS) aligned with FDA standards.
  
• Participate in and support US FDA inspections, internal audits, and third-party audits.
  
• Handle CAPA, deviations, change controls, and investigations related to regulatory compliance.
  

Cross-Functional Collaboration

• Coordinate with Manufacturing, QA, QC, R&D, Validation, and Supply Chain teams to ensure compliance.
  
• Provide regulatory guidance during product development, scale-up, and technology transfer.
  

Training & Guidance

• Conduct training programs on 21 CFR and FDA compliance requirements for internal teams.
  
• Act as a subject matter expert for regulatory and compliance-related queries.

Skills & Competencies

• Strong knowledge of 21 CFR regulations
  
• Excellent documentation and regulatory writing skills
  
• Analytical and problem-solving abilities
  
• Strong communication and stakeholder management skills
  
• Attention to detail and compliance mindset
  

Preferred Attributes

• Experience with electronic quality systems
  
• Exposure to global regulatory environments
  
• Ability to work independently and lead initiatives