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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