Job Description:
- Manage post approval submissions for a small group of assigned market
- Manage post approval strategy including timelines and execution in alignment and partnering with key stakeholders to ensure a submission ready dossier for the assigned market(s).
- Liaise with Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets
- Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners
- Capable of authoring some local submission components in relevant databases
- Ensure submission packages are reviewed against local requirements for consistency and completeness
- Ensure thorough understanding and application of the required procedures
- Participate in local and regional regulatory initiatives promoting a culture aligned with company values and which supports compliance, innovation and talent development and retention
Requirements:
- Candidate must possess at least a Bachelor's Degree, Professional Degree, Master's Degree, Business Studies/Management, Medical Science, Pharmacy/Pharmacology or equivalent
- At least 8 year(s) of working experience in regulatory experience in pharma and regulated industry
- Ability on consistently deliver to quality standards, cost and time, according to project timeline, with proven records of contribution
- Knowledge and understanding of regions healthcare regulations and apply them effectively
Interested Applicants:
Kindly send your detailed resume in MS Word format
(Indicating Reason of Leaving, Availability Period, Last Drawn & Expected Salary) to
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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