Regulatory Affairs Officer
Job Description
We are looking for a Regulatory Affairs Officer to support regulatory, compliance, and product registration activities and ensure that company products and documentation meet applicable regulatory requirements. Key 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. Requirements: - Bachelor of Pharmacy (BPharm), Master of Pharmacy (MPharm), or Doctor of Pharmacy (PharmD) from a recognized university. - Previous experience in Regulatory Affairs, Quality Assurance, Pharmacovigilance, or a related healthcare field is preferred. - Knowledge of regulatory requirements and product registration processes is an advantage. - Good understanding of regulatory documentation and compliance requirements. - 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. Preferred Qualifications: - Experience within the pharmaceutical, healthcare, food supplement, or medical device industry. - Familiarity with regulatory authorities and procedures in Bahrain or the GCC is an advantage. - Experience in product registration, regulatory submissions, quality documentation, or pharmacovigilance is preferred.
Requirements
- Education
- Bachelor Of Pharmacy (BPharm), Master Of Pharmacy (MPharm), Or Doctor Of Pharmacy (PharmD) From A Recognized University
- Previous experience in Regulatory Affairs, Quality Assurance, Pharmacovigilance, or a related healthcare field is preferred.
- Knowledge of regulatory requirements and product registration processes is an advantage.
- Good understanding of regulatory documentation and compliance requirements.
- 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.
- Experience in the pharmaceutical, healthcare, food supplement, or medical device industry is preferred.
- Familiarity with regulatory authorities and procedures in Bahrain or the GCC is an advantage.
- Experience in product registration, regulatory submissions, quality documentation, or Pharmacovigilance is preferred.
Benefits
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