Sr. Officer Regulatory Affairs

Roles & Responsibilities

Regulatory Submissions & Filings

• Prepare, review, and submit DMFs, CEPs, and regulatory dossiers for API registration in global markets (USFDA, EMA, WHO, etc.).
  
• Ensure submissions are complete, accurate, and in CTD/eCTD format.
  
• Coordinate with internal teams to gather technical and manufacturing data for filings.
  
• Track submissions, approvals, and queries from regulatory authorities and ensure timely responses.
  

Dossier Preparation & Maintenance

• Prepare and maintain dossiers in compliance with current regulatory standards and GMP requirements.
  
• Update existing dossiers to reflect process or analytical changes.
  
• Review and compile CMC (Chemistry, Manufacturing & Controls) documentation.
  
• Ensure accurate electronic storage and document retrieval systems.
  

Regulatory Compliance & Standards

• Monitor global regulatory changes and implement updates as required.
  
• Support development of regulatory strategies for product approvals.
  
• Participate in regulatory inspections, audits, and internal compliance reviews.
  
• Ensure continuous adherence to international pharmaceutical regulations.
  

Documentation & Control

• Ensure compliance with Good Documentation Practices (GDP).
  
• Maintain regulatory databases, archives, and document control procedures.
  
• Prepare and review regulatory reports, summaries, and submissions.
  
• Safeguard the integrity and completeness of all regulatory documentation.
  

Collaboration & Communication

• Liaise with external regulatory consultants, agencies, and internal teams (R&D, QA, QC, Production).
  
• Provide regulatory guidance for product and process changes.
  
• Present updates and regulatory insights to management.
  
• Participate in meetings, audits, and conferences related to regulatory affairs.
  

Risk Assessment & Mitigation

• Identify potential regulatory risks and conduct impact assessments.
  
• Develop and implement mitigation strategies to ensure compliance.
  
• Monitor regulatory trends to anticipate and address emerging challenges.