Regulatory Associate
1 week ago
About Us:
We are a well-established player in the B2B Pharma raw material industry that has recently launched an exciting new E-commerce platform – CLYZO.
Job Description:
We are an organization with a reputable history of over a decade in the Pharma raw material sector, specializing in excipient products. We are seeking a Regulatory Affairs Associate with experience and expertise in handling technical inquiries and regulatory documentation.
Responsibilities:
- Manage all regulatory documents related to excipients.
- Address technical queries from major pharmaceutical clients.
- Handle technical tasks and document-related activities for excipient manufacturers.
- Create in-house technical documents essential for the promotion of excipient products.
- Understand and provide specific technical documents for manufacturer and product qualification purposes.
- Handle regulatory qualification documents and inquiries for Excipients/inactive substances.
- Coordinate with excipients/inactive substance manufacturers overseas.
- Compare USP/EP/JP Monographs for various excipients/inactive substances.
- Prepare documents for pharmaceutical companies related to Excipients Qualification.
- Conduct Virtual Audits of Pharma Customers for Excipients Qualification.
- Oversee end-to-end Vendor Qualification Process for Excipients Raw Material Products.
Skills required:
- Strong Technical knowledge in Regulatory Guidelines, GMP, and Testing Methods for Excipients.
- Experience in vendor management.
- Minimum of 2 years of similar role experience.
- Preference for candidates with a background in the Pharma industry. We offer competitive remuneration and benefits in the industry. If you believe you are the right fit for this position, we encourage you to apply.
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