Senior Manager, Regulatory Affairs

2 days ago

Galway, Ireland Summit Therapeutics Sub, Inc. Full time

Position will be on-site.Relocation support will be considered for this role.Overview of Role:Reporting to European Regulatory Director, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects.These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.The role is primarily home based out of: UK, Ireland, Germany, Belgium, Netherlands, SwitzerlandRole and Responsibilities:Provide ownership of projects and activities, including clinical trial applications (CTAs) and other European focused MAA pre-submission activities.Contribute and drive the regulatory content and strategy for marketing authorization submissions and pre-MAA submissionsProvide regulatory guidance internally on study-team decisionsUpdate study/project teams of regulatory activities in the context of study team management meetingsManage and track queries, commitments and submissions with reference to regulatory agencies, collaborate with subject matter experts to provide responses as necessary, provide periodic status updates regarding unfulfilled conditions/commitmentsCollaborate with cross-functional study team for planning of regulatory documents, including health authority meetings such as scientific advice, paediatric and/or orphan designation.Contribute to, or lead, internal meetings such as kick off meetings, cross functional project updatesManage/Support internal document processes, including reviewed, finalized, signed-off, and archivingGeneral support of global / other region regulatory submissions and strategic planning as applicableContribute to / and track regulatory compliance pre and post approvalAll other duties as assignedExperience, Education and Specialized Knowledge and Skills:BA/BS degree in the biological or health related sciences required, Master's, PhD or PharmD preferredMinimum 3+ years of experience in Regulatory AffairsMinimum 7+ years of pharmaceutical, biotechnology or life science industry experienceKnowledgeable of EMA and European guidance's, regulations, drug development process, and industry-standard practicesPossess strong written, oral communicationsDemonstrate proven interpersonal skills and experience working cross-functionally throughout the organizationDetail-oriented, ability to work proactively, organize, prioritize, and delegate assigned projectsExperience interacting with CROs e.g. CTAs, Clinical trial activations experience preferredExperience of EU/European health authority systems such as IRIS, CTIS is desirableProficient user of standard MS Office suite (e.g., Word, Powerpoint, Excel), experience using electronic document management systems, and document review tools desirableSummit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.All employment businesses/agencies are required to contact Summit's human resources department to obtain prior written authorization before referring any candidates to Summit.

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