Regulatory Affairs Specialist
Parkville Pharmaceutical...
Posted on 24 Oct
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Experience
2 - 4 Years
Education
Bachelor of Science, Bachelor of Pharmacy(Pharmacy)
Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Assist in coordinating / preparing and reviewing regulatory submissions for Parkville s products in addition to following up the customs clearance whenever needed.
- Keep up to date with economic / registration and submission changes in addition to maintaining regulatory documentation databases and following up any new decisions issued by the Ministry of Health / CAPA
- Make usual visits weekly to the Ministry of Health to check the pipeline status in order to full fill any comments/modifications required from MOH within the registration phase or the variation phase of the products.
- Obtain/distribute updated information regarding domestic laws/guidelines or standards.
- Response to the governmental agencies requests for any information required such as product data and written regulatory affairs statements.
- Review product labeling/batch records/packs / licensing variation/specification sheets and test methods for compliance with applicable regulations and rules.
Desired Candidate Profile
- Education: Bachelor s degree from reputable university {Degree in Pharmacy, Veterinary Medicine, Science is an advantage
- Experience: Previous experience in Pharmaceuticals industry {from 2-4 years in the same position / responsibilities}.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Administration
Keywords
- Regulatory Affairs Specialist
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Parkville Pharmaceutical...