Regulatory Officer

Posted 16 days ago by Sumathi Group, Classification: Health & Medicine


  • Ensure compliance with local and national regulatory requirements for healthcare products, including registrations, licenses, and certifications.
  • Conduct regulatory assessments and audits to identify gaps and develop action plans for compliance improvement.
  • Stay updated with evolving regulatory guidelines, laws, and industry standards and communicate changes to relevant stakeholders.
  • Prepare and submit regulatory documentation accurately and in a timely manner, including new product registrations, renewals, site registrations, variations and post-market surveillance activities.
  • Coordinate with the National Medicines Regulatory Authority (NMRA) during inspections and audits, addressing inquiries and providing necessary documentation and support.
  • Conduct internal training sessions on regulatory compliance to enhance aware- ness and adherence within the organization.
  • Monitor and review product labeling, packaging, and promotional materials to ensure compliance with regulatory guidelines.
    Assist in the preparation and review of Standard Operating Procedures (SOPs) related to regulatory affairs.
  • Participate in cross-functional teams for new product development and launch, providing regulatory guidance and support.


  • Be a Qualified Pharmacist with at least 02 years experience as a Regulatory Officer within the healthcare or pharmaceutical industry
  • Should have a good relationship with NMRA Officials
  • Proficiency in interpreting and implementing regulations, standards, and guidelines with MS Office applications
  • Effective communication skills to collaborate with cross-functional teams and regulatory authorities
  • In-depth knowledge of local and international regulatory guidelines for healthcare products
  • Strong analytical and problem-solving skills to assess and address compliance gaps 
  • Excellent attention to detail and organizational abilities to manage multiple projects simultaneously

The selected candidate can be assured of an attractive and enhanced remuneration package with fringe benefits and a challenging/encouraging working environment.

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