Regulatory Associate II

Employment Type

: Full-Time

Industry

: Miscellaneous



Summary: Technical Regulatory Lead: As technical regulatory lead on development teams, provides technical regulatory expertise and leadership to development project teams (technical development team, regulatory affairs team). Develops and implements fit-for-purpose technical regulatory strategy to support clinical and technical development. Updates partners and functional leadership on key issues as needed. Submission Support Activities: * Coordinate activities required for submission generation and review. Ensure all technical regulatory submissions meet requirements, are accurate and have been checked for compliance as appropriate. * Ensure submissions contain adequate scientific justifications to mitigate risks identified. * Ensures submission are performed per project timelines or timeless agreed with Health Authorities. * Ensures all regulatory correspondence and submission-related documents are archived. * Coordinates responses to regulatory information requests during application review. Regulatory Knowledge: * Applies practical understanding of relevant HA guidelines, 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. 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 internally to facilitate the review and approval of submissions. * Displays high degree of capability in assigned written and oral presentation. REQUIREMENTS: * Bachelor's degree or higher in a relevant scientific discipline. * Minimum 5 years industry experience * 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 * 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 CMC experience in pharmaceutical and regulatory environment ???????

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