Regulatory Associate II
Employment Type: Full-Time
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.
* 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.
* 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.
* 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