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Job Description
Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. They also provide responses to regulatory agencies regarding product information or issues. `
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies
- Examining the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
- Staying informed about any changes in legislation etc.
- Develop and maintain standard operating procedures or local working practices.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Develop regulatory (Import Approvals & registration ) strategies and implementation plans for the preparation and submission of new products.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Prepare monthly reports.
- Perform overall quality control of work procedures (schedule, plans, personnel’s performance) and report regularly on projects status.
- Perform any other related task as assigned
Job Requirements
Job Requirements
- Bachelor’s Degree in Science, Chemistry, Biochemistry, Pharmacology, Biology, or related field; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required
- Planning and organizational skills.
- 8 to 10 years at least of experience in the same role
- Speaks and writes English fluently
- Business Background is preferred
- SAP experience is a Must
- Prefer Medical devices or pharmaceutical industry
- Exceptional leadership, communication, and interpersonal skills.
