Job Description:

• Accountable for creating post approval submissions for Drug Products for country acceptability in terms of content, according to local regulations and requirements for assigned markets
• Ensure Dossiers (electronic,paper copy, HA portal) are produced, dispatched to assigned markets according to their defined filing plan and submission ready
• Ensure processess transparency and excellence in execution of regulatory strategies
• Collaboration across the regulatory organization with stakeholders (such as Product Strategist and in-market Strategists) to deliver efficiencies in Regulatory submissions and processes
• Ensure submission planning and forecasting tool is utilized to update timeline when required, communicate changes to relevant partners
• Capable of authoring some local submission components in relevant databases ensuring submission package reviewed against local CMC requirements for consistency and completeness

Requirements:

• Minimum 5 years of regulatory affairs experience in pharma and regulated industry
• A good balance of Regulatory and Business acumen
• Fair knowledge and understanding of drug/healthcare regulations and ability to apply them effectively
• Attention to detail and analytical skills

Interested Applicants

Kindly send your detailed resume in MS Word format

(Indicating Reason of Leaving, Availability Period, Last Drawn & Expected Salary) to

selina.lim@experis.com.sg

Personnel Reg No: R1333126

EA Licence No: 02C3423

We regret that only shortlisted candidates will be notified

Selina Lim Siew Yen EA License No.: 02C3423 Personnel Registration No.: R1333126

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