Senior RA Manager (Compliance)

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About the job

  • UK

Do you have regulatory experience in a pharmaceutical company? Are you open to exploring a new career opportunity?

Invenia Group is partnered with a leading international pharmaceutical company, that is seeking an experienced and driven professional to take on the role of Senior Regulatory Manager for Compliance. The Senior RA Manager is responsible for overseeing the management of all regional regulatory affairs activities and cross-functionally support other departments, such as Pharmacovigilance and Quality on these matters.

Key Responsibilities:

If successful, you will be responsible for the following:

  • Performing regulatory compliance activities such as system & procedure development, change controls, CAPA execution and creating and developing RIMS to oversee this, while ensuring commercial and regulatory compliance is met.
  • Develop a labelling and medical information tool to maintain product information, quality and accuracy.
  • Oversight of pre-licensing product information, all national phase activities related to existing and new MAA’s, and all post-licensing activities (variations, renewal, PSURs etc.)
  • Reviewing outcome of PSUSR/ PRAC procedure and execution of same in existing license portfolio.
  • Acting as a point of contact for regulatory affiliates and distributors regarding all regulatory matters, including all types of licensing activity.
  • Support regulatory-related audits by competent authorities e.g. GVP audits
  • Assist the QPPV/dQPPV with PV compliance activities
  • Training and dissemination of guidelines prepared by national regulatory agencies and notified Bodies
  • Managing regulatory support and client relation on outsource supporting works (translation agency, CMO activities, distributors, PV projects etc.

Skills & Experience Required:

We are looking for someone with regulatory experience in a pharmaceutical company, as well as proven experience with working in EU post approval procedures. You should have extensive experience in dossier submissions with a comprehensive understanding of National submission requirements and a proven record of working experience of National, DCP & Centralized procedure submission requirements, as well as the following:

  • Proven track record and broad knowledge of requirements with safety variation and ability to prepare the appropriate dossiers for EU submissions.
  • Proven working record with plant packaging machines & the packaging lines, creating correct first-time mockups
  • MS Excel, Word and PowerPoint knowledge to at least an intermediate level
  • Fluent English

If you are interested in proceeding with this opportunity, please apply to find out more.