Regulatory Affairs Manager
6 months ago
**Regulatory Affairs Manager**:
- **Job Summary**
Tasks and Responsibilities
- contributing to the organization’s strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters;
- writing and periodically updating drug regulatory affairs (DRA)-related local SOPs;
- reviewing draft registration files and submitting new and amended registration dossiers to obtain and maintain registration;
- providing input as required, for example on technical matters, for the investigational medicinal product dossier (IMPD);
- ensuring that quality standards are met, and all submissions meet agreed deadlines;
- maintaining contacts and sharing relevant information with stakeholders, internally and externally, including liaising with regulatory authorities;
- preparing and participating in presentations on regulatory affairs matters, and providing advice to manufacturers and scientists;
- submitting periodic reports, such as safety update reports to the Medicines Evaluation Board
(MEB).
- Develops and maintains professional relationships in federal, state, and local regulatory agencies.
- Maintains current knowledge of regulations applicable to the company.
- Responds to requests for information from regulatory bodies.
- Serves as a liaison between regulatory bodies and operating divisions of the company.
Education and skills
- **Required Skills/Abilities**_
- Extensive knowledge of applicable government regulations (SFDA)
- Ability to inform and educate managers and department heads on regulations and polices that require compliance.
- Excellent written and verbal communication skills.
- Excellent analytical and problem-solving skills.
- Excellent strategic planning skills.
- Proficient with applicable database and compliance software.
- Proficient with Microsoft Office Suite or similar software.
- **Education and Experience**:_
- Bachelor’s degree in pharmacy.
- Three years of related experience required.
- This position is for Saudi Nationals only.
نوع الوظيفة: دوام كامل
الراتب: ﷼15,000.00 - ﷼25,000.00 لكل شهر
الخبرة:
- الخبره: 3 سنوات (مفضل)
الترخيص/الشهادة:
- صيدلي (مفضل)
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