Regulatory Affairs S....
Regulatory Affairs Specialist
Posted on :
15-01-2024
Employer Active
1 Vacancy
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Jobs by Experience
2 - 4 years
Monthly Salary
Not Disclosed
Salary Not Disclosed
Nationality
Any Nationality
Gender
Male
Vacancy
1 Vacancy
Posted on :
15-01-2024
Job Description
Req ID : 2234258
- Governance of the Kuwait regulatory landscape and requirements for local registration: preparing, submitting and negotiating with regional regulatory bodies to obtain approval or clearance of premarket registration as well as post market compliance
- Provides expertise in translating regulatory requirements into practice, workable plans
- Collaborate with the regional regulatory team and local regulatory lead to ensure compliance to local market regulations and technical file submissions
- Collaborate with Product Managers and Marketing teams: Assures timely regulatory clearances and registrations for new product launches, renewals to ensure timely market access, continuous product availability and compliance
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements
- Compiles all materials required in submissions, license renewal and annual registrations
- Identifies the regulatory impact : changes of labelling, manufacturing, marketing for regulatory compliance, submitting the required change notifications
- Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes
- Directing interactions with regulatory agencies on defined matters, working with advocacy principles to ensure rapid and optimal registration for new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products
- Delivering regulatory focus within the region with the team of regional regulatory responsible. Ensuring communication, disseminating relevant information to key stakeholders Building capacity across the organisation for regulatory topics using community forums, emails and face to face meetings
- Educates internal and external customers regarding submissions issues regarding products. Acts as subject matter expert to management and project teams on critical regulatory issues
- May serve as a contact with affiliates to achieve regulatory compliance through regional regulatory network
- To collaborate with the Product Quality and Safety lead regarding the requirements for Adverse event reporting and recall management ensuring compliance to regional regulations
- To actively support local organizations and marketing, sales and logistic departments to obtain documents related with regulatory affairs such as certificates, declarations, etc., needed ad required for tender processes, contracts and /or any commercial activity
- To support audit activities, ensuring compliance to the divisional requirements
- Check/approve promotional materials as routed through internal tools for compliance to promotional practice regulations and the external necessary approvals
Employment Type
Full Time
Department / Functional Area
Key Skills
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