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Regulatory Associate II
Ref No.: 18-03107
Location: South San Francisco, California
Duties:
Regulatory Knowledge Has practical understanding of relevant HA guidelines, Roche GSPs and expected submission requirements and content to manage the scope of activities and submissions assigned Actively consults line management, SMEs and approved internal Regulatory Standards and information databases to ensure strong understanding of historical precedent for topics assigned General Organizational and Operational Knowledge Knowledgeable in technical regulatory department processes required for scope of assignments (assigned by mgr) Has sufficient technical understanding of process and product development processes to complete assignment within assigned scope Executes work priorities and timelines with consultation of line mgr and TRL Submission Support Activities Coordinate activities required for submission generation and review Ensure all technical regulatory submissions meet are accurate and have been checked for compliance as appropriate Ensure submissions contain adequate scientific justifications to mitigate risks identified in the Readiness to Submit processes and TRT risk assessments Ensures submission are performed per project timelines or timeless agreed with Health Authorities. Ensures all regulatory correspondence and submission-related documents are archived Communication Effectively communicate with line mgr, TRT members and stakeholders to inform of project status and strategy in accordance with defined role Communicates project challenges to line mgr in an appropriate and timely manner. Communicate internallly to facilitate the review and approval of submissions. Displays high degree of capability in assigned written and oral presentation

Skills:
Manage multiple projects independently Work in teams in a matrix environment Work with others to generate support for assigned projects Apply Regulatory and relevant technical knowledge to projects. Volunteer for new tasks and projects. Complete assigned tasks and projects with direct management oversight. Communicate with regulatory, cross-functional personnel, partners and HA authorities in support of project goals under general supervision Able to communicate drivers for project goals internally

Education:
Bachelor's degree or higher in a relevant scientific discipline.