Regulatory Associate

2 weeks ago


Thāne, Maharashtra, India Pharmonix Biologicals Pvt. Ltd. Full time

About Us:

We are a well-known player in the B2B Pharma raw material industry and have recently launched a fantastic new E-commerce platform called CLYZO.

Position: Regulatory Affairs Associate

Job Description:

We are an organization with over a decade of experience in the Pharma raw material sector, specializing in excipient products. We are currently seeking a Regulatory Affairs Associate with expertise in handling technical inquiries and regulatory documentation.

Responsibilities:

  • Managing all regulatory documents related to excipients
  • Resolving technical queries from major pharmaceutical clients
  • Handling technical and document-related tasks for excipient manufacturers
  • Preparing internal technical documents necessary for promoting excipient products
  • Providing specific technical documents for manufacturer and product qualification
  • Dealing with regulatory qualification documents and queries for Excipients/in-actives
  • Coordinating with overseas Excipients/in-actives manufacturers
  • Comparing USP/EP/JP Monographs for various excipients/in-actives
  • Preparing documents for Pharmaceutical companies regarding Excipients Qualification
  • Conducting Virtual Audits of Pharma Customers for Excipients Qualification
  • Managing end-to-end Vendor Qualification Process for Excipients Raw Material Products

Skills required:

  • Strong Technical Knowledge of Guidelines, GMP, and Testing Methods for Excipients
  • Experience in Vendor Management
  • Minimum of 2 years in a similar role
  • Preference for candidates with a background in Pharma

Remuneration and benefits offered are among the best in the industry. If you believe you are the right fit for this position, we welcome your application and look forward to connecting with you.


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