Senior EU Regulatory Affairs Lead — MA Submissions

Organon Northwest Europe

Amsterdam

Hybrid

EUR 90,000 - 130,000

Full time

14 days+

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Job summary

Organon Northwest Europe seeks an experienced Regulatory Affairs professional to coordinate and support EU regulatory submissions, maintain marketing authorizations, and guide strategy across Centralized, MRP, DCP, and national procedures. You will lead cross-functional collaboration, manage timelines, and ensure compliance across Europe with EMA interactions.

Responsibilities include developing regulatory strategies, reviewing submissions, and contributing to governance processes while staying

Qualifications

Fluent in written and spoken English; another European language is highly desirable.
Experience with regulatory information management systems (Veeva, Ennov) and standard office tools.
Bachelor's degree in life sciences or pharmacy/pharmacology or equivalent.

Responsibilities

Coordinate and support regulatory activities to maintain registrations and obtain new marketing authorizations across Europe.
Develop regulatory strategies and oversee submissions for Centralized, MRP/DCP, and national procedures.
Collaborate with cross-functional teams and liaise with EU regulatory authorities and country affiliates.
Keep up-to-date with EU regulations, prepare documentation, and manage timelines.
Provide regulatory input for governance meetings and support non-product related initiatives.