Regulatory Associate I
One DNA Way South San Francisco, CA 94080
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- Has 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 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
- 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
- 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
- Bachelor's degree or higher in a relevant scientific discipline.