Senior Regulatory Project Manager

 

Work Your Magic with us! Start your next chapter and join EMD Serono.

 

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.

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

An exciting new opportunity has arisen to join the company as Regulatory Project Manager in Healthcare. As a key partner to the Global Regulatory lead, you will support that the regulatory strategy will be executed as planned. You will create project plans for submissions to Health Authorities worldwide with a focus on initial clinical trial and/or marketing authorization applications and major variations. You will set-up kick-off meetings and regular Submission Task Force meetings for submission preparation with relevant stakeholders. In close interaction with the Regulatory Lead, cross-functional teams, and submission management, you will assess and resolve any issue impacting timeline, and perform spot checks on published outputs. In addition, you will be responsible for providing transparency on Global Regulatory budget demands and tracking of actual spending (if applicable). You are expected to contribute to the improvement of planning capabilities within Regulatory and to increase efficiency in GRA-internal processes. You will manage and improve tools and templates for project management that ensure compliance with regulatory strategy, regulatory project timelines and Health Authority requirements. You will represent Regulatory Project Management in Regulatory Sub teams and Global Project teams.

 

Location: Remote with expectation to travel to Billerica, MA as needed.

 

Who you are:

Minimum Qualifications:

• Bachelor's Degree with 5-8 years of experience OR Master’s degree with 3-6 years of experience or Ph.D wit 2-5 years of experience.

• Experience in a Regulatory environment.
• Experience in project management and technology solutions

Preferred Qualifications:

• Fluent in English, and a second language would be an asset.
• In-depth knowledge of regulatory applications needed to support the regulatory function according to the role; experience in EU CTIS portal of advantage
• Excellent communication and interpersonal skills
• Strong team player with ability to work with multidisciplinary teams within a matrix and in an international environment.
• Project Management certifications are a plus

 

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!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html