Regional Regulatory Affairs Manager (pharma)
Singapore, Singapore
Job Description
Our client is in the pharmaceutical industry with an expanding portfolio
Roles and Responsibilities
- Responsible for GDA and NDA across various product portfolio
- Develop regulatory strategies for new product submissions with local RA, global partners,
commercial, business development, legal and supply chain - Conduct due diligence for potential products to determine the feasibility &
risk level of registration in country of interests - Conduct gap analysis of dossier and propose strategies to mitigate risks
- Regulatory intelligence: keep abreast of latest regulatory requirements and policies, identify
new updates and inform cross-functional stakeholders on the impact and mitigation plans - Regulatory excellence: monitor/track new product submissions and approvals in RA tracker
and report to management on monthly basis - Ensure good documentation in SharePoint accordance to company SOPs
- Assist in quarterly and annual regulatory budget planning
What you should do now Apply to this job ad or send your CV across to me at e.ng@brunel.net for a confidential discussion. (Registration Number: 199603098R | Consultant License Number 53132073A)
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Job Detail
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Job IdJD1331450
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSingapore, Singapore
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EducationNot mentioned