Demo

Senior Regulatory Project Manager (all genders), full/part-time

EMD Serono, Inc.
Darmstadt, IN Full Time|Part Time
POSTED ON 2/20/2025
AVAILABLE BEFORE 3/19/2025
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.

Your Role

Join us as a Regulatory Project Manager in Healthcare, where you'll be a vital partner to the Global Regulatory lead. You will ensure the regulatory strategy is executed effectively by creating project plans for submissions to Health Authorities globally, focusing on initial clinical trials and marketing authorization applications. You'll organize kick-off and Submission Task Force meetings, assess timeline impacts, and perform spot checks on outputs. Additionally, you'll provide transparency on budget demands, enhance planning capabilities, and improve project management tools to ensure compliance with regulatory requirements. Represent Regulatory Project Management in various teams and drive efficiency.

Who You Are

  • Bachelor's degree with 5 years, Master’s with 3 years, or PhD with 2 years of experience.
  • Experience in a Regulatory environment and project management.
  • Fluent in English; a second language is an asset.
  • In-depth knowledge of regulatory applications, especially in late clinical development or registration phases.
  • Excellent communication and interpersonal skills.
  • Strong team player able to collaborate in a matrix and international environment.
  • Project Management certifications are a plus.

Location: Darmstadt, Germany or Billerica, MA, with an expectation to travel 10%.

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!

Apply now and become a part of our diverse team!

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