Associate Director Regulatory CMC Combination Products (remote)

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 Arrairs 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:

• Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
• Over 8 years of experience in regulatory affairs of drug-device combination products and/or medical devices for worldwide submission
• Proven expertise of building global regulatory strategy including building submissions-dossier for global submissions especially in the EU (MAA/Notified Body Opinion – NBOp, CTA) and US (IND, NDA/BLA (for combination products), 510K, PMA)

Preferred Qualifications

• Proven track record of effective collaboration with the regulatory authorities in form of scientific advice meetings and demonstrated ability to act as a credible, influential, respected spokesperson during such interactions.
• Prior experience working with CMC and connected drug/device combination products for medicinal products is desirable.
• Good understanding of the drug-device combination and medical-device – regulatory framework in EU, US, and international countries such as ICH, EU-MDR, MDSAP, ISO-13485, cGMP for combination products, QMS and technical file for medical-devices, eCTD and MCDG guidelines.
• Strong team player; able to work within a highly multidisciplinary environment. Effective communication with team members and stakeholders with diverse backgrounds.
• Fluency in English is mandatory.

Possible location:  Boston (US), OR  Eysins (Switzerland) OR Darmstadt (Germany)

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