وظائف شاغرة بالسعودية مطلوب "Regulatory Affairs Manager - Pharmaceutical Solutions Industry" للعمل Jobs in Saudi Arabia Job Details : وظائف شاغرة بالسعودية مطلوب "Regulatory Affairs Manager - Pharmaceutical Solutions Industry" للعمل Jobs in Saudi Arabia
This vacancy is available in Jeddah and Riyadh.
• Review registration files prepared for submission to the regulatory agencies. Lead the submission of documents to SFDA, and other regulatory agencies.
• Develop and maintain Technical Files for CE marking.
• Provide response to queries and comments raised by SFDA or other regulatory agencies.
• Lead and guide the team members to respond to any queries raised by the regulatory authorities for the products submitted for registration.
• Provide the product development teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
• Manage final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals.
• Act as a fully functional member of multi-disciplinary teams and provide expertise on regulatory matters. Partner with R&D, Marketing and other internal departments to confirm the regulatory requirements necessary to place products on domestic and international markets.
• Represent the company before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
• Defend company business interests in international standardization groups.
• Participate in the development or implementation of clinical trial protocols.
• Provide technical leadership and vision through the interpretation of new and emerging international regulatory trends pertinent to local business needs and develop and implement strategies and projects to optimize regulatory performance.
• Keep updated on current knowledge of relevant regulations, including proposed and final rules.
Job Details
| Posted Date: | 2018-10-10 |
| Job Location: | Jeddah , Saudi Arabia |
| Job Role: | Management |
| Company Industry: | Pharmaceutical |
Preferred Candidate
| Career Level: | Management |
| Nationality: | Saudi Arabia |
| Degree: | Master's degree |
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