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About the Role

Provide procedural, administrative, and planning support for new marketing authorization applications and variation submissions in the EU, UK, Switzerland, and non-EU South Eastern European countries under supervision. Work on products approved through Centralized and Decentralized/MRP procedures, collaborating with cross-functional teams. The department strives for operational excellence, aiming to ensure innovative medicines reach patients.

Responsibilities

Provides administrative support during filling and review of new product registrations and post-approval submissions in the EU, UK, Switzerland, and non-EU SEE countries.
Plan and coordinate regulatory submissions to ensure timely delivery.
Draft and organize regional administrative documents and liaise with internal teams for completeness and accuracy.
Work closely with Regulatory Operations and Country RA Managers to establish submission timelines and align on submission strategy and execution.
Oversee translation processes to meet EMA requirements for centralized procedures.
Coordinates new product artwork development and/or artwork updates implementation.
Keep regulatory databases updated and ensure adherence to EU legislation and procedural requirements.
Act as a subject matter expert in workstreams and process improvement initiatives.

Requirements

University degree in life sciences or related field.
Up to 5 years of experience in the pharmaceutical industry with knowledge of drug development and approval processes.
Strong organizational and project management abilities with the ability to manage multiple tasks and prioritize them efficiently.
Familiarity with EU regulatory procedures (CP, DCP, MRP) and Module 1 requirements.
Ability to work in an international environment and coordinate multiple stakeholders.
Detail-oriented with strong document review and QC skills.
Proactive, solution-oriented, and eager to contribute to process improvements.
Experience with AI-enabled tools (e.g. for document management, data review, process efficiency, or knowledge retrieval).
Willingness to travel up to 5% for job-related activities.

Skills

Accountability
Adaptability
Audits Compliance
Detail-Oriented
EU Pharmaceutical Regulations
Communication
Pharmacovigilance
Process Improvements
Project Management
Regulatory Compliance
Regulatory Operations
Regulatory Strategy Development
Regulatory Submissions
Digital & AI literacy (use of AI-enabled tools to support regulatory, administrative, and process-improvement activities)
Cross-Functional Collaboration
Drug Development
Drug Regulatory Affairs
Employee Training Programs
EU Regulations
Foreign Policy
Global Communications
On Time Deliveries
Pharmaceutical Development
Pharmaceutical Regulatory Affairs
Product Approvals
Public Administration
Regulatory Affairs Compliance
Regulatory Affairs Management
Translation Management

Location

Brussels (BE)
Oss (NL)
London (UK)

Work Type

Hybrid

Experience Level

Up to 5 years

Education Level

University degree in life sciences or related field

About the Company

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.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.
Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.