Consultant/Manager - RPi

3 weeks ago


Dublin, Dublin City, Ireland PharmaLex Full time

Job Title: Regulatory Affairs Consultant at PharmaLex


Job Description


  • To provide key support to the Director/Principal Consultant in all matters relating to the provision of services to clients and customers.
  • Main focus areas include technical delivery of client projects, acting as a QP/RP/RPi for client projects in the UK, and working both individually and as part of a team under the guidance of the Senior Consultant.

Principal Responsibilities:

  • Liaising with customers to determine their needs, manage client projects, and conduct Quality Audits in line with PharmaLex procedures.
  • Acting as a QP/RP/RPi on client authorizations and supporting companies in improving their Quality Systems.
  • Advising clients on regulatory requirements and ensuring customer satisfaction.

RP/RPI Responsibilities

To act as RP/RPi for clients in the UK, responsible for:
  • Ensuring compliance with regulatory directives for medicinal products.
  • Completing supply chain checks and confirming the status of unique identifiers for Prescription Only Medicines.
  • Adhering to additional national law requirements for products.

Project Management
  • Managing client projects technically, ensuring project plans' completeness, implementing timelines, and monitoring progress against key milestones.

Training
  • Developing training material for courses, delivering training to clients, and maintaining technical knowledge through CPD.

Business Development/Sales & Marketing
  • Providing input on regulatory standards, industry best practices, and trends for business/product development opportunities.
  • Engaging with existing and potential clients to expand the client base and increase sales.

Communication
  • Preparing company publications, newsletters, and liaising with industry sources for content ideas.

Budgeting
  • Participating in the annual budgeting process.

Customer Service
  • Resolving customer queries effectively, handling internal/external contacts, and liaising with regulatory authorities on behalf of clients.

Your Profile

  • 3rd Level Qualification in Science or Quality Management.
  • 10 years experience in Quality Assurance or Quality Compliance role – GMP/GDP.
  • High level of Computer Literacy and competency – Microsoft Office, Microsoft Project.
  • QP or RP Status.
  • Vendor Auditing Experience.

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