Regulatory Compliance Specialist
4 days ago
Chemill Pharma Ltd. is a dynamic pharmaceutical company seeking an experienced Regulatory Affairs Manager to ensure seamless regulatory submissions and compliance with country-specific guidelines.
We are offering a competitive salary of $120,000 - $180,000 per annum for this role, depending on experience.
Job Description:- Dossier Review and Evaluation
The successful candidate will be responsible for reviewing and evaluating assigned dossiers received from manufacturers in accordance with country-specific registration guidelines. They will ensure all documents are complete and error-free before final review and submission.
- Compilation and Submission
They will compile dossiers for final review and submit them directly to country-specific regulatory authorities' online platforms as per regulatory requirements.
- Communication and Coordination
The candidate will communicate with manufacturers regarding document revisions or additional document requirements prior to final review and submission. They will handle deficiencies related to assigned products and liaise with manufacturers to resolve issues promptly.
- Query Management
They will respond to all CORP queries and dossier queries raised by the NMPA in a timely manner.
- Artwork Approval
The candidate will approve artwork preparation and revisions according to regulatory requirements by coordinating with the designer. They will ensure all final artworks prepared by Chemill are sent to manufacturers for confirmation before submission.
- Tender Document Preparation
They will arrange tender documents under Tender Schedule B, including USP or BP compliance reports from manufacturers if required. The candidate will work with manufacturers and the Chemill BD team to gather samples.
- Follow-Up and Data Collection
They will follow up with manufacturers to obtain requested data related to tenders, dossiers, CORP, and tender queries. The candidate will arrange re-labelling of samples as per registered artworks if manufacturers are unable to support before the tender closing date.
- Team Management
The successful candidate will recruit team members, set objectives, and monitor performance. They will generate ideas to accelerate regulatory tasks and processes.
- Planning and Coordination
They will plan, initiate, and coordinate the regulatory schedule leading to timely submissions and approvals of regulatory amendments and variations.
- Reporting and Tracking
The candidate will update the registration tracker and prepare monthly reports.
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