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EU Regulatory Lead (all genders) at The businesses of Merck KGaA, Darmstadt, Germany
Darmstadt, Hesse, Germany -
Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

0.0

Posted On

22 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Drug Development, Matrix Leadership, Influencing Skills, Interpersonal Communication, English Communication

Industry

Pharmaceutical Manufacturing

Description
Your role The EU Regulatory Lead (EU RL) is responsible for the regulatory strategy and execution for their assigned projects in their EU region and respective countries. The EURL represent and provide input for the respective EU region at the GRST. The person may provide direct input to the GPT in case of major region, particularly where the GRL is not in that region. The person lead the respective regional regulatory sub-team and drive the regulatory submission in the EU region. The person ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance. Partnering with Regulatory Project Management and Submission Management is a key stakeholder management. The person participate in cross-functional and GRA initiatives. Who you are Considerable Regulatory Affairs experience Advanced scientific degree or equivalent Minimum 3 years of experience in drug development, preferably in Regulatory Affairs Skilled in matrix leadership Influencing and interpersonal communication skills Excellent spoken and written English Department: HC-RD-ROS Global Regulatory Onc Strategy Job evaluation: AT - Expert 3
Responsibilities
The EU Regulatory Lead is responsible for the regulatory strategy and execution for assigned projects in the EU region. They lead the regional regulatory sub-team and drive regulatory submissions to ensure ongoing compliance.