Specialist, Regulatory Affairs FDF

2 days ago

Gurgaon, Haryana, India Centrient Pharmaceuticals Netherlands Full time

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.

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