Job title: Regulatory Operations Manager
A global pharmaceutical business is seeking a Regulatory Operations Manager to join their team. This role will be responsible for Providing expertise on IDMP readiness and any related regional and global initiatives.
- Support the Global Regulatory Information Management team on the incorporation of ISO requirements into company systems and work on evaluation related processes and workflows.
- Manage IDMP data requests. Generate the reports, analyse the data, and distribute to appropriate stakeholders.
- Create Standard Operating Procedures, Work Instructions, Job Aides, etc.
- Adherence to all applicable policies and procedures, including those relating to GMP, GCP, Quality and Compliance.
- Substantial experience within Regulatory Operations and Pharmaceutical industry.
- In depth knowledge and understanding of pharmaceutical science processes and standards including xEVMPD, ISO IDMP, EMA SPOR, Pharmacopeia, Standard Terms/Referential, CMC and regulatory dossier lifecycle, MedDRA codes, etc.
- Knowledge of regulatory information management systems.
- A life sciences degree would be beneficial.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via Freddie.firstname.lastname@example.org