Regulatory Affairs (senior Executive)
Kuala Lumpur, Malaysia
Job Description
About Our Client
Our client is a rapidly expanding pharmaceutical company (HQ's in Kuala Lumpur) looking to escalate their business. Challenging scope of work, providing an outstanding opportunity for personal and technical growth.
:
- Managing the entire process for regulatory approval of poison drugs
- Prepare dossiers for new product submissions
- Implement regulatory plans and ensure submissions are done in a timely manner
- Engaging with government bodies such as the MDA, NPRA & KKM to ensure compliance with local guidelines
- Regular reporting on registration status to management
- Strategy meetings with other cross-functional teams such as marketing, supply chain etc to discuss product pipelines and registration plan
- Keep up-to-date on market trends and devise new registration strategies
- Review advertising materials, product labels, and product information sheet to ensure compliance with guidelines
- Manage and develop direct reports
- Bachelor's/Masters degree in pharmacy
- Possessing a pharmacist license from Malaysia is a must for this role
- Must also be certified in managing Poison compliant with License A
- 5 years Experience in regulatory affairs in a medical device or pharmaceutical company
- Familiarity in liaising with local regulatory bodies such as NPRA (National Pharmaceutical Regulatory Agency) or KKM (Kementerian Kesihatan Malaysia)
- Strong initiative and ability to take the lead on projects
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Job Detail
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Job IdJD860975
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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:5000 - 6000 per month
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Employment StatusPermanent
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Job LocationKuala Lumpur, Malaysia
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EducationNot mentioned