- To be the main contact/representative for Regulatory Affairs (RA) in business initiatives/projects involving or impacting data, systems and processes (Enterprise Content Management, Product Lifecycle Maintenance, Change Control)
- To drive business initiatives/projects involving or impacting RA data, systems and processes (Regulatory Information Management system, eCTD publishing system)
- To ensure RA data compliance with external requirements (main focus on Europe (SPOR, PLM)), through adequate processes and systems
- To ensure RA data are current, accurate, usable and adequately linked to the relevant systems and processes in place in the business
- To ensure appropriate support and training are in place for the relevant RA community concerning the systems and processes in use in the business
- To drive optimisation of the systems and processes in use in the business;
- To create and maintain processes that enable centralised medicinal publishing within the business unit (EU) with a view to expand those processes to the wider RA Community.
- To support equipping the Regulatory Affairs function for further digital transformation including integration of data and Artificial Intelligence solutions
- To manage a team of Operations Administrators (currently two team members but with planned future expansion)
- Bachelor or Master's degree in Life Science or Information Technology
- 8 years of experience in a relevant regulatory environment ideally part of it within an Operations role
- Great communication skills.
- Good project management skills.
- 'Give it a go' and positive attitude being keen on creative and problem-solving thinking whilst being thorough and focused with attention to detail.
- The ability to support several concurrent projects/products in a flexible manner both autonomously and in a team environment.
- Must be collaborative and able to influence change.
- Inclusive and customer service oriented.
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Senior Manager Regulatory Operations - Warsaw, Polska - Perrigo
Opis
Description Overview
Within the Consumer Self-Care International business unit (main focus on Europe), lead the growing and evolving Regulatory Affairs Operations team responsible for centralised Regulatory systems & processes and Regulatory data management & compliance.
Scope of the Role
The main objectives of the job are
Experience Required
Użytkownicy zawodu Senior Manager Regulatory Operations w Warsaw
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Dorota Starzynska
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Slava Pronin
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Pete Bishton
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Kuldeep Singh
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