# Specialist, Regulatory Affairs FDF

**Company:** [Centrient Pharmaceuticals Netherlands](http://jobs.workable.com/companies/esDKab91anXXVrcyjKXcZM.md)
**Location:** Gurugram, India
**Workplace:** hybrid
**Employment type:** Full-time
**Department:** Regulatory Affairs

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## Description

Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are:  obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.

Key Individual Accountabilities

-   Collection of information and preparation of dossiers and variation packages as and when required.
-   Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA managers
-   Support in activities related to pharmacovigilance
-   Support in evaluation of CMC data required to support dossiers and variation packages.
-   Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures
-   Creation and updating of product information texts
-   Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global RA environment.
-   Cross functional alignment internally and externally in relation to regulatory updates, variations packages, and regulatory procedures.
-   Contribute to write and review SOP’s related to department.
-   Report all regulatory data related to activities to ensure RA workplan and MA databases are up to date
-   Support in MDS compliance and creation
-   Escalating to senior RA staff in case of complex regulatory issues or risks including implications.

**Key Shared Accountabilities**

-   Ensure support to RA-FDF team and other disciplines within FDF and Centrient in order to meet objectives
-   Execute on performance management and act accordingly
-   Compliance for FDF

## Requirements

Academic degree in Pharmacy, Chemistry or Biomedical field.

-   Having at least 3-5 years’ experience in regulatory affairs and/or relevant health registration environments of medicinal products, preferably in the generic pharmaceutical industry.
-   Being familiar with the registration procedures and requirements in the global environment.
-   Having followed a wide range of professional training in Regulatory affairs field.
-   Accuracy, creativity, trouble-shooting capability.
-   Good communicator (open minded, transparent), good command of English

## Benefits

Truly global work environment.

High performance culture.

Ability to make a difference.

Best in class compensation.