Nivagen Pharmaceuticals - Manager/Assistant Manager - Regulatory Affairs (US/EU)

Roles and Responsibilities

- Knowledge of US-ANDA, EU Regulations, acquaintance with EMeA, EDQM and other related websites

- Thorough knowledge of ICH guidelines related to various aspects of Pharmaceutical Manufacturing

- Review and compilation skills for ANDA, EU MAAs for EU filings (Modules 1, 2, 3, and 5)

- Experience on various dosage forms like Injectable, OSDs, Oral Liquids.

- Good communication skills for coordination with various stakeholders like RnD, Mfg Site, QA, Sourcing Team for New Filings and related Deficiency Responses to the query received from EU agencies in co-ordination with R&D/ Mfg Site, Regional office, QA, Sourcing Teams and Clinical counterparts in the organization.

- Co-ordinate with external graphic designer for preparation and updation of labelling (mock-up labels, PIL etc.) for original submission and during deficiency responses

- Good knowledge of softwares : Microsoft Office, Word, Excel, PowerPoint etc.

- Support to stakeholders for post approval regulatory activities like Product Launch, Artwork Development

- Good knowledge of US-ANDA; EU GMP requirements related to various aspects of Pharmaceutical Manufacturing

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