Director, Global Regulatory Affairs - Oncology
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 Director, Global Regulatory Affairs - Oncology is located on site at the Billerica, MA facility with domestic and international travel required.
Your role:
The Director, Global Regulatory Affairs - Oncology is responsible for the global regulatory strategy and execution for assigned projects in the oncology pipeline.
Key Accountabilities
Represent Regulatory Affairs in Global Project Team(s) for your assigned project(s)
Lead the global regulatory sub-team (GRST) for your assigned project(s). Ensure alignment of all GRST functions
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
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.
Develop optimal regulatory strategies that are aligned with the development plan for assigned projects.
Matrix leadership role of GRST - ensure project resource requirements are suitably managed.
Participate in cross-functional and GRA initiatives.
Who you are:
Minimum Requirements
Advanced degree and at 6 +years of relevant experience
3
years of recent oncology development experience
Experienced strategist with a record of successful HA (Health Authority), interactions with FDA (Federal Drug Administration) and/or EMA (European Medicines Agency)
Up to 15% domestic and international travel
Preferred Requirements
Demonstrated strong matrix leader.
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.htmlEstimated Salary: $20 to $28 per hour based on qualifications.
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 Director, Global Regulatory Affairs - Oncology is located on site at the Billerica, MA facility with domestic and international travel required.
Your role:
The Director, Global Regulatory Affairs - Oncology is responsible for the global regulatory strategy and execution for assigned projects in the oncology pipeline.
Key Accountabilities
Represent Regulatory Affairs in Global Project Team(s) for your assigned project(s)
Lead the global regulatory sub-team (GRST) for your assigned project(s). Ensure alignment of all GRST functions
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
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.
Develop optimal regulatory strategies that are aligned with the development plan for assigned projects.
Matrix leadership role of GRST - ensure project resource requirements are suitably managed.
Participate in cross-functional and GRA initiatives.
Who you are:
Minimum Requirements
Advanced degree and at 6 +years of relevant experience
3
years of recent oncology development experience
Experienced strategist with a record of successful HA (Health Authority), interactions with FDA (Federal Drug Administration) and/or EMA (European Medicines Agency)
Up to 15% domestic and international travel
Preferred Requirements
Demonstrated strong matrix leader.
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.htmlEstimated Salary: $20 to $28 per hour based on qualifications.
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