Director, Global Regulatory Affairs

EMD Serono, Inc. - Billerica, MA

Hiring: Director, Global Regulatory Affairs Company: EMD Serono, Inc. Location: Billerica, MA Job Posted Time: 2026-09-13 11:46:26 Employment Type: On-site Target Skills & Keywords : Project Management, Risk Management, Stakeholder Management About the job Experience: •6 years of relevant regulatory experience with at least 3 years in Oncology. •At least 6 years of relevant regulatory experience with at least 3 years in Oncology. Required Skills: •Lead and oversee defining and executing the global regulatory strategy for designated oncology programs, ensuring timely and compliant approvals across geographies. Qualifications: •Advanced degree (e.g., PhD, PharmD, MD, or equivalent). •Demonstrated track record as an effective strategy developer and HA/EMA/FDA interaction expert. •Proven ability to lead in a matrixed, cross-functional environment. •Strong written and spoken English communication skills; proficiency in other languages is a plus. •Excellent project management and influencing skills; able to drive programs across complex organizations. •Strategic thinker with a hands-on, execution-focused mindset. •Strong stakeholder management and negotiation capabilities. •Demonstrated capacity to manage competing priorities with a clear gaze on risk management and compliance. •Patient-centric mindset and commitment to scientific rigor. •: This is an onsite role based in our Billerica, MA facility requiring and onsite presence at least 3 days per week. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!