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حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيحالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيAbout the job
We are seeking a highly motivated and detailoriented immediate joiners Regulatory Affairs specialist to join our consulting company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development approval and marketing of pharmaceutical products globally (internationally).
Responsibilities:
Submission and Approval Process:
Preparation and submission of Manufacturing License Application (MLA)
Preparation and submission of Technical/Site Transfer Applications
Preparation and submission of Marketing Authorisation Applications
Lifecycle Maintenance:
Preparation and submission of documentation for postapproval applications including but not limited to Variations Renewals MAH Transfers/COAs Labeling
Compliance:
Monitor and maintain uptodate knowledge of national European and International guidelines/legislation
Ensuring compliance with all regulatory processes in readiness for both internal and external audits
Ensuring compliance with the regulations of the assigned Countries within European and International Regions
Communication:
Act as a liaison between the pharmaceutical company and the regulatory agencies
Support internal requests for information
Experience:
58 years of relevant experience in Regulatory Affairs Internationally
Lifecycle maintenance experience
Experience with: MLA MAA CTD Variations Renewals Labeling Applications
Experience working with Global Market
Experience with software packages and databases (Microsoft Office Suite Veeva Vault (or comparable EDMS) LorenZ Trackwise PromoMat etc.)
Good organizational skills and communication skills
Ability to prioritize and deliver highquality work
Experience in people management/coordination is a plus
Experience in promotional/nonpromotional activities is a plus
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Remote Work :
No
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