Regulatory Affairs Specialist: Submissions & Compliance

Confidential; Jid Hafs; On-site; BHD 20,000 - 39,000; Full time

Job summary

Confidential in Bahrain seeks a Regulatory Affairs professional to manage product registration renewals, variations and approvals; prepare and submit documents to authorities; ensure compliance with regulations; coordinate with regulators, manufacturers, suppliers, and internal teams.

You will review product information, labels and supporting materials for regulatory compliance, monitor submission statuses, maintain records, support importation documentation, and assist QA and Pharmacovigilance

Qualifications

• Bachelor of Pharmacy, Master of Pharmacy, or Doctor of Pharmacy from a recognized university.
• Experience in Regulatory Affairs, Quality Assurance, or Pharmacovigilance preferred.
• Knowledge of regulatory requirements and product registration processes is an advantage.
• Strong written and verbal communication skills in English.
• Good organizational and time-management skills.
• Strong attention to detail and ability to manage multiple tasks and deadlines.
• Ability to communicate and coordinate effectively with internal and external stakeholders.
• Proficiency in Microsoft Office and general document management.
• Ability to work independently and as part of a team.

Responsibilities

• Manage regulatory activities related to product registration renewal variation and approval.
• Prepare review and submit regulatory documents to the relevant authorities.
• Ensure compliance with applicable regulatory requirements guidelines and company procedures.
• Coordinate with regulatory authorities manufacturers suppliers and internal departments.
• Review product information labels artworks and supporting documents for regulatory compliance.
• Follow up on regulatory submissions and respond to authority queries when required.
• Maintain accurate and up-to-date regulatory records and documentation.
• Monitor product registration status approvals licenses and renewal timelines.
• Support regulatory documentation related to product importation and other business activities.
• Assist with Quality Assurance and Pharmacovigilance activities when required.
• Monitor updates and changes in applicable regulatory requirements and guidelines.
• Provide regulatory guidance and support to relevant departments.
• Perform other regulatory and compliance-related duties as assigned

Skills

Regulatory communication

Organizational skills

Time management

Attention to detail

Independent worker

Microsoft Office

Education

Bachelor's/Master/PharmD in Pharmacy

Tools

Microsoft Office

Job description

Confidential in Bahrain seeks a Regulatory Affairs professional to manage product registration renewals, variations and approvals; prepare and submit documents to authorities; ensure compliance with regulations; coordinate with regulators, manufacturers, suppliers, and internal teams.

You will review product information, labels and supporting materials for regulatory compliance, monitor submission statuses, maintain records, support importation documentation, and assist QA and Pharmacovigilance