Regulatory Affairs Coordinator
1 week ago
At Er-Kim, we are seeking a skilled Regulatory Affairs Specialist to join our team.
About the Role- This position is responsible for ensuring compliance with current Ministry of Health requirements for registration and variation files.
- The ideal candidate will also be responsible for preparing food supplement dossiers according to current Ministry of Agriculture requirements.
- Additionally, the successful candidate will prepare pricing submissions & reimbursement dossiers of products, sales permission dossiers, SmPC/PIL submissions, and answers to MOH's correspondences in due time.
- Registration and Variation Files: Prepare and submit registration and variation files to regulatory authorities in accordance with current Ministry of Health requirements.
- Food Supplement Dossiers: Develop and maintain knowledge of current Ministry of Agriculture requirements for food supplement dossiers.
- Pricing Submissions: Prepare and submit pricing submissions & reimbursement dossiers of products to regulatory authorities.
- Sales Permission Dossiers: Prepare and submit sales permission dossiers to regulatory authorities.
- SmPC/PIL Submissions: Prepare and submit SmPC/PIL submissions to regulatory authorities.
- Correspondence: Respond to queries and correspondence from regulatory authorities in a timely and professional manner.
- Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or Biology.
- Advanced command of written and spoken English.
- Proficiency in MS Office applications.
- Excellent interpersonal, communication, and presentation skills.
- Ability to work effectively in a team environment.
- Good follow-up and strong planning skills.
- No restriction for travel.
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