Regulatory Officer

DUTIES AND RESPONSIBILITIES:

• 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.

THE IDEAL CANDIDATE SHOULD POSSESS:

• 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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