What are the responsibilities and job description for the Associate Director Regulatory CMC Combination Products (remote) position at EMD Serono, Inc.?
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 :
Associate Director Regulatory Affairs Medical Devices is responsible for the regulatory strategy of our drug-device combination products for our medicinal products.
- Develop Global regulatory strategies for submissions and approvals of drug-device combination products (including co-packaged medical devices) for marketing authorization applications including LCM activities within our medical-device and drug / device combination products portfolio.
- Implementing drug-device combination products in clinical-trial program aimed at medicinal products.
- Implement regulatory strategy for Drug / Device combinations products, in conjunction with technical, development, quality, commercial, IP and business development teams by supporting projects and work streams according to agreed deliverables, timelines and budget.
- Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant internal and external stakeholders (such as health authorities) leading to early engagement to accelerate development.
- Work effectively in the broader matrixed organization to deliver an aligned and successful regulatory strategy.
- Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities.
Who You Are :
Minimum Qualifications :
Preferred Qualifications :
Possible location : Boston (US), OR Eysins (Switzerland) OR Darmstadt (Germany).
The Pay Range for this position : $118,600 to 178,000.
Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits : medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
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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Salary : $118,600 - $178,000
