Senior Manager Regulatory Affairs

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, pediatric 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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