Regulatory Document Coordinator
6 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Jamjoom Pharma. The successful candidate will be responsible for preparing dossiers for submission, collaborating with internal/external stakeholders, and maintaining project status.
Responsibilities- Collecting and evaluating scientific data for dossier preparation and submission.
- Developing clear arguments and explanations for new product registration.
- Preparing renewal and variation files by collecting, collating, and evaluating scientific data.
- Collaborating with internal/external stakeholders to ensure availability of required documents/samples.
- Maintaining project status through implemented system(s)/software(s).
- Utilizing specialist computer software(s) and resources.
- Evaluating Change Requests and full products' life cycle management.
- Uploading product information on relevant portals.
- Bachelor of Pharmacy/Science or Master of Pharmacy/Science degree.
- 1-3 years' experience in regulatory affairs.
- Regulatory and scientific knowledge for product registration.
- Excellent oral and written communication skills.
- Strong interpersonal and collaboration skills.
- Proficiency in MS Office Applications and eCTD.
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