Regulatory Affairs Officer

We are looking to hire a Regulatory Affairs Officer (NMRA) for one of our clients.

Qualifications:

• Bachelors degree in Pharmacy Pharmaceutical Sciences Regulatory Affairs or a related field. Advanced degree preferred.
• Minimum of 2 years of experience in regulatory affairs within the pharmaceutical healthcare or related industry.
• Thorough understanding of regulatory requirements and processes related to the National Medicines Regulatory Authority (NMRA) and other relevant regulatory bodies.
• Experience in preparing and submitting regulatory submissions including registration dossiers variations renewals and responses to regulatory queries.
• Strong analytical communication and problemsolving skills with attention to detail and accuracy.
• Ability to work independently and collaboratively in a fastpaced dynamic environment.
• Proficiency in regulatory affairs software and Microsoft Office Suite.

Responsibilities:

• Ensure compliance with regulatory requirements set forth by the National Medicines Regulatory Authority (NMRA) for the registration labeling packaging and marketing of pharmaceutical products.
• Stay informed about NMRA regulations guidelines and updates and ensure that products meet all applicable standards.
• Manage the registration process for new pharmaceutical products including preparing and submitting registration dossiers to the NMRA.
• Liaise with NMRA officials and regulatory authorities to facilitate the timely approval of product registrations and resolve any issues or concerns that may arise.
• Maintain accurate and uptodate documentation related to product registrations submissions approvals and postmarket surveillance activities.
• Ensure that all regulatory documents and records are organized accessible and compliant with NMRA requirements.
• Monitor regulatory developments trends and updates related to pharmaceutical regulations guidelines and best practices.
• Provide recommendations and insights to internal stakeholders regarding regulatory implications and strategies.
• Collaborate with internal teams including R&D Quality Assurance Marketing and Legal to ensure alignment with regulatory requirements throughout the product lifecycle.
• Provide regulatory guidance and support to crossfunctional teams on regulatory matters and projects.

If you are interested please send your CV to or apply below.

Remote Work :

No