How you’ll spend your day
Compiling and reviewing of the Annual Report and ensuring it is submitted prior to the commitment date (at minimum no later than the due date).
Assessing, reviewing and approving the change controls initiate by manufacturing sites.
Compilation and submission of post approval supplements (CBE 0, CBE 30, PAS) in US.
Coordinating the retrieval of supporting documentation in accordance with the Annual Report schedule.
Retaining all supporting documentation as required in completing an Annual Report.
Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late.
Decision Making:
Own authority
Organisation of own workload to meet set departmental and Company targets.
To support the execution of the department’s work plan.
Referred: Understanding the need to refer issues and decisions that are outside of the individual’s experience and competence to line manager.
Your experience and qualifications
Qualification:
Degree in science/life science/pharmacy or equivalent qualification(s)
Experience:
Five to Six year experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
Desirable to have experience with preparation and compilation of Annual reports.
Handling of change controls and process.
Experience and through knowledge in assessing and filing of US post approval supplements.
Knowledge:
Desirable to have knowledge of US regulatory applications.
Understanding of processes and departments within a pharmaceutical company.
