Regulatory Operations Manager

  • Permanent
  • England
  • Negotiable GBP / Year

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.

Responsibilities:

  • 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.

Requirements:

  • 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.hill@pharma-partners.co.uk

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