Job duties:
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 Aspen internal and external stakeholders
Local Super User for Regulatory Information Management System - good understanding on the business processes and regulatory procedures, support on the decisions related to the system on behalf of the affiliate, cascading information and provide support and training to the local users in the affiliate, create and maintain local procedures with respective the operational items of the system incorporating the principles of Group Policies and guidance documents
Organise the required access to Aspen 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.
The authority and resources required to fulfil the responsibilities of the Regulatory and Artwork Coordinator Europe CIS will be provided by management.
This includes: PoA for marketing/cession notifications and sunset clause exceptions
Requirements
Educated with a BSc, MSc, PhD in a Life Science related degree, or a Pharmacist
Minimum 2 years experience 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
Advanced level in Microsoft Excel and PowerPoint
Good working knowledge of RIMS
What we look for in candidates
At Aspen, our culture is built on core values that drive our success and foster a supportive, innovative environment.
We value Teamwork, where diverse perspectives and skills come together to enhance creativity and problem-solving.
Innovation is at our core, as we continually seek better ways to achieve our goals and remain at the forefront of our industry.
We demonstrate Commitment by exceeding expectations and building long-term relationships, while always striving for Excellence in everything we do.
Our foundation of Integrity ensures that honesty, ethical behavior, and accountability guide our decisions.
By proceeding with this job application, we understand that you share these values, and we look forward to reviewing your application and engaging with you further.
Work Level
Skilled
Job Type
Permanent
Salary
Market Related
EE Position
No
Location
Ireland