Senior Global Regulatory Affairs CMC Manager

 

Work Your Magic with us!  

 

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.

 

Your role:

You are responsible for driving all CMC Regulatory activities for assigned large molecules (biotech) commercial products and projects worldwide. In this role you develop, author and own the relevant Global Regulatory CMC Life Cycle Strategy and all CMC Dossier types, such as NDAs/MAAs, variations, amendments, renewals, annual reports, and answers to health authority questions.

You serve as the contact point for CMC Regulatory topics and act as liaison in-between technical CMC-, quality-, supply- and Regulatory Affairs functions and provide strategic support and advice to the CMC team, the Global Regulatory Strategy Team (GRST), the Global Product Supply Team (GPST), and other cross-functional project teams (e.g., Tech Transfer Project Team). Upon collecting and interpreting country-specific regulatory CMC requirements you translate them into deliverables. You plan and align CMC Regulatory activities and develop submission roll-out and implementation plans, in close collaboration with key stakeholders. You lead and participate in internal and cross-functional, international initiatives.

 

Location: Remote within the United States (Significant interaction with EMEA and expected to work EST working hours)

 

Who You Are:

Minimum Qualifications:

• Bachelor's degree in Life Sciences such as Biochemistry, Biotechnology or a related discipline
• Min. of 5 years of CMC regulatory and/or CMC technical experience within the pharmaceutical / biotech industry (e.g., in regulatory affairs, quality control, analytical development or manufacturing / process development)
• Ability to develop and prepare successful regulatory CMC strategies for variations, renewals, or new registrations (new MAAs)
• You are the expert for US CMC regulations, guidance and regulatory trends.
• Experience in preparation and management of regulatory CMC documentation, such as a full international submission (new product application) or complex variations
• Practical experience in one of the following areas is an asset: manufacturing process development, technical transfers, validation or analytical development, control strategies.
• Sound understanding and in-depth knowledge of global pharmaceutical legislation.

 

Preferred Qualifications:

• Master’s or PhD in a scientific discipline preferred.
• Experience working in global matrixed environment.
• Ability to work in teams, good interpersonal skills. 
• Assertive, proactive, flexible, speak up personality.
• Ability to think strategically.
• Knowledge of other European languages such as French, Italian or German is an asset.

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