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, Switzerland
Role 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 submissions
Provide regulatory guidance internally on study-team decisions
Update study/project teams of regulatory activities in the context of study team management meetings
Manage 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/commitments
Collaborate 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 updates
Manage/Support internal document processes, including reviewed, finalized, signed-off, and archiving
General support of global / other region regulatory submissions and strategic planning as applicable
Contribute to / and track regulatory compliance pre and post approval
All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
BA/BS degree in the biological or health related sciences required, Master's, PhD or PharmD preferred
Minimum 3+ years of experience in Regulatory Affairs
Minimum 7+ years of pharmaceutical, biotechnology or life science industry experience
Knowledgeable of EMA and European guidance's, regulations, drug development process, and industry-standard practices
Possess strong written, oral communications
Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization
Detail-oriented, ability to work proactively, organize, prioritize, and delegate assigned projects
Experience interacting with CROs e.g. CTAs, Clinical trial activations experience preferred
Experience of EU/European health authority systems such as IRIS, CTIS is desirable
Proficient user of standard MS Office suite (e.g., Word, Powerpoint, Excel), experience using electronic document management systems, and document review tools desirable
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All employment businesses/agencies are required to contact Summit's human resources department to obtain prior written authorization before referring any candidates to Summit.