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Regulatory Affairs Operations
At a Glance
- Location
- CZE - Central Bohemian - Prague (Five)
- Work Regime
- hybrid
- Employment
- Full time
- Experience
- 2–4 years
- Posted
- 2026-03-23
Key Requirements
Domain Knowledge
- Manufacturing
- Pharmaceutical
- Regulatory
Requirements
Business Process Modeling, Change Management, Communication Strategy Development, Digital Strategy, Pharmaceutical Manufacturing, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
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Responsibilities
The Regulatory Affairs Operations will support regional activities associated with the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
With some understanding of regulatory affairs and supporting business processes, this role provides support across a portfolio of systems and their related capabilities including but not limited to the following: content management for regulatory submissions; submission planning & execution; health registration & regulatory information management systems.
This role partners with Innovation & Information Management (IIM), Business System Owners (BSOs) and key regional stakeholders to ensure the successful regional implementation of GRACS Regulatory systems and to support continuous enhancements of capabilities and processes.
The Regional SPRI will support all countries in the region for assigned capabilities and will represent regional needs for system and process changes in global project activities.
They are responsible for understanding the underlying business processes that the systems support and where necessary, work with Business Process Owners (BPOs) to adapt those procedures to align with regional needs/ country-specific requirements.
They will be responsible for evaluation of regional data and creating / implementing action plans for the region to address data quality issues.