Associate Director Regulatory Affairs Oncology

Posté 09 mai 2024

Billerica, Massachusetts - United States

Demander un identifiant 274849

 

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.

 


Location:

The Associate Director Regulatory Affairs location is flexible, including remote work arrangement within the US.

 

Your role:

The Associate Director Regulatory Affairs - Oncology is responsible for the regulatory strategy development and execution for their assigned projects in the United States, and supporting other North American countries.

 

Key Accountabilities:

  • Represent and provide input for your respective region to the GRST (global regulatory sub-team).  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
  • Function as direct contact to a local Health Authority i.e., Federal Drug Administration and 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.

 

Who you are:

Minimum Requirements:

  • Advanced degree and 3+ years’ experience in drug development, preferably in regulatory affairs
  • Up to 15% domestic and international travel

 

Preferred Requirements

  • 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!
 
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

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