Specialist, Regulatory Affairs FDF

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.