Job Description

About Us:

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https://www.clyzo.com/aboutus

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An established player in the B2B Pharma raw material space has recently launched an exciting recent E-commerce platform – CLYZO

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Position- Regulatory Affairs Associate

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Job Description:

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An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having experience and knowledge of handling technical queries and regulatory documentation.

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Responsibilities:

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- Handling entire regulatory documents of excipients.
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- Resolving technical queries of big pharmaceutical clients
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- Handling technical matters & document related work of excipient manufacturer.
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- Preparation of in house technical documents, required for promotion of excipient products.
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- Should be able to understand & provide specific technical documents, for manufacturer & product qualification.
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- Regulatory qualification documents and queries for Excipients / in-actives,
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- Co-ordination with Excipients / in-actives manufacturer overseas
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- USP/EP/JP Monograph comparison for various excipients / in-actives
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- Preparing documents of Pharmaceutical companies, w.r.t Excipients Qualification
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- Handling Virtual Audits of Pharma Customers w.r.t Excipients Qualification
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- Handling Vendor Qualification Process end to end for Excipients Raw Material Products.
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Skills required:

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- Good Technical Know-how, w.r.t Guidelines / GMP / Testing Methods (for Excipients)
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- Vendor management experience
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- Minimum 2 years of experience into similar role
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- Candidates from Pharma background will be preferred.
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Remuneration and benefits will be best in industry.

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If you feel you are right fit for this role, please apply we would love to connect with you!

📌 Regulatory Affairs Associate (Thane)
🏢 Pharmonix Biologicals
📍 Thane