Sr Regulatory Submissions Project Manager at Millipore Corporation in BILLERICA, Massachusetts

Job Description:

An exciting new opportunity has arisen to join the company as Regulatory Project Manager in Healthcare. As a key partner to the Global Regulatory lead, you will support that the regulatory strategy will be executed as planned. You will create project plans for submissions to Health Authorities worldwide with a focus on initial clinical trial and/or marketing authorization applications and major variations. You will set-up kick-off meetings and regular Submission Task Force meetings for submission preparation with relevant stakeholders. In close interaction with the Regulatory Lead, cross-functional teams, and submission management, you will assess and resolve any issue impacting timeline, and perform spot checks on published outputs. In addition, you will be responsible for providing transparency on Global Regulatory budget demands and tracking of actual spending (if applicable). You are expected to contribute to the improvement of planning capabilities within Regulatory and to increase efficiency in GRA-internal processes. You will manage and improve tools and templates for project management that ensure compliance with regulatory strategy, regulatory project timelines and Health Authority requirements. You will represent Regulatory Project Management in Regulatory Sub teams and Global Project teams. Location: hybrid with expectation to travel to Billerica, MA as needed.



Who you are:




Minimum Qualifications:



Bachelor's Degree with 5-8 years of experience OR Master's degree with 3-6 years of experience or Ph.D wit 2-5 years of experience.Experience in a Regulatory environment.Experience in project management and technology solutions



Preferred Qualifications:



Fluent in English, and a second language would be an asset.In-depth knowledge of regulatory applications needed to support the regulatory function according to the role; experience in EU CTIS portal of advantageExcellent communication and interpersonal skillsStrong team player with ability to work with multidisciplinary teams within a matrix and in an international environment.Project Management certifications are a plus