Regional Regulatory Lead

Vor 6 Tagen

Darmstadt, Deutschland Merck KGaA Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

The Regional Regulatory Lead is responsible for the regulatory strategy and execution for their assigned projects in their region / country.

**Your role**
- Represent and provide input for your respective region at the GRST. May provide direct input to the GPT in case of major region, particularly where the GRL is not in that region.
- Lead the respective regional regulatory sub-team.
- Drive the regulatory submission in your respective region. Ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance. Partner with Regulatory Project Management and Submission Management.
- May act as direct contact to a local HA (e.g. FDA or EMA). Lead the direct interactions with the respective local HA in this case.
- Contribute to the global regulatory strategy with local / regional strategy for assigned projects.
- Matrix leadership role of respective Regional Regulatory ST.
- Participate in cross-functional and GRA initiatives.

Scope of People Responsibility
- No direct reports. Matrix leadership of functional and cross-functional teams.

**Who you are**
- Advanced degree and at least 3 years experience in drug development, preferably in regulatory affairs.
- Demonstrated matrix leadership skill.
- Excellent spoken and written English.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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