Specialist, Regulatory Affairs FDF

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.