Regulatory Affairs & Quality Assurance


General Information


Company:
Confidential
Job Type:
Health Care/ Pharmaceutical
Location:
Lebanon - Beirut
Date Posted:
Nov 28, 2022
Salary:
Unspecified
Employee Type:
Full-Time Employee
Gender:
Both

Description


Tasks & Duties

- Studying scientific and legal documents.
- Gathering, evaluating, organizing, managing and collating information in a variety of formats.
- Ensuring compliance with the regulations set by the MOH and OPL.
- Maintaining familiarity with company product ranges.
- Planning, undertaking and overseeing product trials and regulatory inspections.
- Keeping up-to-date with changes in regulatory legislation and guidelines
- Maintain contact with regulatory authorities and principals.
- Identify relevant guidance documents, international standards or consensus standards and provide interpretive assistance.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Be aware of pricing laws and changes in Lebanon and country of origins. Prepare price analysis before any submission and provide it to the pricing committee in order to decide if the project is to be maintained or not.
- Initiate and follow up on external audits and assure continued compliance.
- Approve promotional and technical literature for regulatory compliance.
- Conduct quality audits
EDUCATIONAL BACKGROUND
• Bachelor degree in Pharmacy or Business administration
• Regulatory Affairs Certification is a plus.
Experience
• Minimum of one year experience that is directly related to the duties and responsibilities specified
Skills & Knowledge
- Have excellent management skills.
- Is a decision maker.
- Have excellent computer skills.
- Have good communication skills.
- Pay attention to details

Company Profile