Global Regulatory Lead - Darmstadt, Deutschland - Merck KGaA Darmstadt Germany

Merck KGaA Darmstadt Germany

Geprüftes Unternehmen

Darmstadt, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Ganztags

Beschreibung

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.

Everything we do in Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living.

We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries.

We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency.

Together, we push the boundaries of science to make more possible for our customers.

Your Role:

You represent Regulatory Affairs in Global Project Team(s) for your assigned project(s). You will lead regulatory sub-team (GRST) for your assigned project(s).

Ensure alignment of all GRST functions and drive the regulatory submission process for all types of submissions through to approval.

This includes the management and coordination of the preparation of all regulatory documentation, and ensuring all submission deliverables are of high quality.

Partner with Regulatory Project Management and Submission Management.

You will ensure optimal management of major regulatory agency interactions for your assigned projects including preparation of briefing materials, co-ordination of rehearsals and minutes.

This may be done by an experienced Regional Regulatory Lead with strong support from the GRL. As well you will Develop optimal regulatory strategies that are aligned with the development plan for assigned projects. You are seasoned working in a matrix leadership role of GRST - ensure project resource requirements are suitably managed.

Who you are:

Advanced University degree on related fields and at least 6 years of relevant experience.
A minimum of 3 years of recent oncology experience.
Experienced strategist with a record of successful HA interactions with FDA or EMA.
Demonstrated strong matrix leader.
Excellent spoken and written English.
You are passionate about patients and are committed to staying up to date with the latest regulations and best practices in oncology

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