Senior Manager, Global Regulatory Affairs CMC

 

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.

 

Your Role:

The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide, and serves as the Regulatory Affairs CMC contact point and acts as the liaison with the GHO and R&D functions, being the contact person for all Regulatory CMC topics.

 

Location: Hybrid (3x/week) in Billerica, MA office

 

Key Accountabilities:

Global Product Oversight:

• Ensures global product oversight for the regulatory CMC part of the product / project

 

Regulatory CMC strategy and Health Authority interactions:

• Develops, defines and is accountable for the Global Regulatory CMC strategy for development and Life Cycle Management programs. Leads and drives global regulatory CMC strategy for the assigned projects/products in target regions/countries. This encompasses responsibility for the Regulatory CMC topics, risk assessment & mitigation, regulatory CMC strategic support and advice to interdisciplinary internal teams
• Leads HA meetings and represents GRA in Health Authority interactions on CMC topics

 

Management of CMC Regulatory Activities; CMC Dossier generation:

• Responsible and accountable for driving all regulatory CMC activities for assigned projects/products. Develops, authors and owns the CMC dossier Strategy Document as well as all CMC Dossier types; being accountable  for CMC Dossier content and content decision of all CMC Dossier types such as IMPD/IND, BB (incl. meeting request), variations, amendments, renewals, Module 1 CMC regulatory binding documents, Annual reports, IB CMC, ATOs up to approval.
• Provides the Global Regulatory CMC advice & expertise in cross-functional project teams.
• Acts as liaison between Global Health Operations and R&D functions as single point of contact for all CMC topics.
• Accountable and responsible to provide country specific regulatory CMC requirements for CMC dossier strategies and plans.
• Regulatory CMC assessment of in-and out licensing projects for business development (Due Diligence).

 

Regulatory intelligence and knowledge management:

• Is the expert for CMC regulations, guidance, regulatory trends and competitive environment, incl. accelerated pathways, CMC innovations
• Reviews draft and newly released laws and guidance on behalf of the Company. If required, being a member in trade associations. Leading and participation in internal as well as cross-functional, international initiatives.

 

Global Regulatory Affairs CMC coordination:

• Support development and execute initiatives
• Plans regulatory CMC activities and develops submission roll-out plans, in close collaboration with key stakeholders

 

Who You Are:

Minimum Qualifications:

• Degree in a Life Science or related discipline (e.g. MSc or equivalent degree, PhD in a scientific discipline is preferred)
• 7+ years of pharmaceutical industry experienc