Regulatory Affairs & Registration Officer

Tawteen; Muscat; On-site; OMR 6,000 - 12,000; Full time

Job summary

Tawteen is seeking a Regulatory Affairs and Registration Officer in Muscat to manage product registrations and regulatory submissions. You will ensure compliance with MOH Oman regulations, review licenses and technical documents, and coordinate with MOH and other authorities.

The role requires a Bachelor’s in Pharmacy or related field, familiarity with CTD/eCTD, and strong command of English, with attention to detail and deadlines being essential.

Qualifications

• Bachelor's degree in Pharmacy or related field.
• Experience in Regulatory Affairs and Product Registration is preferred.
• Knowledge of MOH Oman regulations and CTD/eCTD dossier preparation is an advantage.
• Familiarity with CTD/eCTD dossier preparation and regulatory documentation is an advantage.
• Strong understanding of pharmaceutical regulations, guidelines and compliance requirements.

Responsibilities

• Prepare, compile and submit regulatory dossiers for pharmaceutical and medical products.
• Manage new product registrations, renewals, variations and post-registration activities.
• Coordinate with MOH and other regulatory authorities.
• Review product documentation including licenses, product information and technical documents.
• Follow up on submissions and respond to queries from authorities.

Skills

CTD/eCTD

Regulatory submissions

MS Office

English

Detail-oriented

Deadline-driven

Education

Bachelor's degree in Pharmacy or related field

Job description

Regulatory Affairs amp Registration Officer

Location Muscat Sultanate of Oman Employment Type Full-Time Department Regulatory Affairs

We are seeking a detail-oriented and motivated Regulatory Affairs amp Registration Officer to join our team The successful candidate will be responsible for managing product registration activities regulatory submissions and ensuring compliance with the applicable regulatory requirements of the Ministry of Health in Oman

Key Responsibilities

• Prepare compile and submit regulatory dossiers for pharmaceutical and medical products
• Manage new product registration renewals variations and post-registration regulatory activities
• Coordinate with the Ministry of Health MOH and other relevant regulatory authorities
• Review product documentation including certificates licenses product information and technical documents
• Follow up on regulatory submissions and respond to queries from regulatory authorities
• Ensure compliance with local regulatory requirements and applicable guidelines
• Coordinate with international manufacturers and suppliers to obtain required regulatory documents
• Maintain and update product registration records licenses and regulatory databases
• Monitor regulatory updates and communicate changes to relevant departments
• Ensure timely completion of regulatory submissions and registration procedures

Qualifications Requirements

• Bachelor s degree in Pharmacy or a related pharmaceutical health science field
• Previous experience in Regulatory Affairs and Product Registration is preferred
• Knowledge of pharmaceutical registration requirements and MOH regulations in Oman
• Familiarity with CTD eCTD dossier preparation and regulatory documentation is an advantage
• Good understanding of pharmaceutical regulations guidelines and compliance requirements
• Proficiency in Microsoft Office
• Excellent written and verbal communication skills in English
• Strong organizational skills attention to detail and ability to meet deadlines

Required Skills

• Regulatory Affairs Pharmaceutical Product Registration Regulatory Submissions
• CTD eCTD
• MOH Regulatory Compliance Dossier Preparation
• Review License Renewals
• Variations Regulatory Documentation Stakeholder Coordination