Skills: Regulatory Submissions, Electronic Common Technical Document (eCTD), Guidelines/GMP/Testing Methods for Excipients, Vendor Management
Responsibilities:
- Manage entire regulatory documentation for excipients.
- Resolve technical queries from major pharmaceutical clients.
- Handle technical matters and documentation for excipient manufacturers.
- Prepare in-house technical documents for excipient product promotion.
- Understand and provide specific technical documents for manufacturer and product qualification.
- Handle regulatory qualification documents and queries for excipients/in-actives.
- Coordinate with excipients/in-actives manufacturers overseas.
- Compare USP/EP/JP monographs for various excipients/in-actives.
- Prepare documents for pharmaceutical companies regarding excipients qualification.
- Manage virtual audits of pharmaceutical customers concerning excipients qualification.
- Oversee vendor qualification process end-to-end for excipient raw material products.
Preferred Background:
- Pharma industry experience is preferred.
- Strong technical know-how regarding guidelines, GMP, and testing methods for excipients.
- Vendor management experience.
Remuneration: Competitive, with industry-leading benefits.