For our Client - an international pharmaceutical company, we are looking for an experienced person for the position:
Regulatory and Artwork Coordinator Europe CISMiejsce pracy: Warszawa
Main Objective of Role:
- Support the Regulatory projects driven from the region and ensure the involvement and regional regulatory input into the global and regional cross-functional projects.
- Lead the initiatives aimed at the continuous improvement of regulatory and artworks related processes
- Coordinate the artworks tasks with internal and external stakeholders
- Organise the required access to systems and SharePoint for external consultants
- Providing trainings to the new team members on the systems used, e.g., artwork system
- Supports initiatives aimed at the continuous improvement of regulatory and artworks related processes, e.g., preparing/updating SOPs for the regulatory department and progressing them through the system
- Coordinates the monitoring of Sunset Clause and applies for Sunset Clause exemptions
- Processes invoices of RA/PV service providers
- Assist in the qualification of suppliers/service providers in the region
- Assists in issuing and management of power of attorneys
- Processes parallel import notifications to group and commercial functions and handles and archives documentation and samples
- Assist in the implementation of new deals and projects
- Raises change requests to the relevant group structure for incorporation of RA activities into the central plans
- Coordinate the compiling of the regulatory/artworks intelligence
- Ensure information exchange and periodic reporting to the Head of RA (Europe)
- Work as part of a multi-disciplinary team on projects as and when required, providing regulatory input and guidance
- Always perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines
- Implement Standard Operating Procedures where relevant to the regulatory function
- Ensure that accurate records are kept and maintained in a secure manner as per Good Documentation Practice, ensure proper data management and archiving
- Any other duties as assigned by Senior Management
Requirements:
- High level education such as BSc, MSc, PhD or Pharmacist in Life sciences or related area
- At least 3-5 years in a similar role in Regulatory/Artwork Department in the pharmaceutical industry in an international environment
- Ability to work in a complex matrix team environment and with both internal and external partners
- Fluent English skills
The client offers:
- attractive salary plus a bonus system and work tools
- work in a global company with top products
- dynamic development and work in a competent and committed team
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
