Project Manager, Regulatory Affairs
Regulatory Project Manager, will be responsible for the coordination, prioritization and tracking regulatory deliverables and submissions associated with the company’s research, development and post-marketing activities for a variety of therapeutic areas.
Reports to: Associate Director, Regulatory Operations
Location: Thousand Oaks, CA
- Identify and document all regulatory project deliverables from each functional area by project for global regulatory submissions.
- Maintain detailed timelines for global regulatory strategies for assigned therapeutic areas in US, EU, CAN, and ROW, and ensure planning and coordination of activities via the Submission Teams.
- Ensure product specific regulatory strategies are documented, maintained, updated, kept on schedule and proactively communicated.
- Facilitation of product specific regulatory meetings and functional sub-teams by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines.
- Work with the regulatory leads and project team to identify and mitigate risks to meeting regulatory submission goals, address any delays and escalates when necessary.
- Provides Project Management services as needed to support regulatory projects for non-product related initiatives.
- Conduct lessons learned sessions to identify areas for improvement and maintain tracker for implementation of short and longer-term corrective and improvement measures into standard regulatory project management practices.
Skills and Abilities:
- Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
- Requires global eCTD knowledge (eg, US, EU, CA).
- Understanding of the overall drug development process, early and late stage experience is a must (eg, IND, CTAs, Amendments, BLA, NDA, MAA).
- Ability to manage complex projects with ambitious milestones in high pressure circumstances
- Excellent project management skills; highly organized and detailed oriented
- Flexible, with positive attitude, and highly self-motivated. Can work independently, able to prioritize, and works effectively under pressure.
- Excellent written and verbal communication skills.
- Strong customer focus and interpersonal skills
- Ability to effectively manage multiple projects simultaneously and in a timely manner
- Motivated with a "can do" attitude.
- A person who operates effectively in a smaller company and works well across teams within a matrixed organization.
- High bar personal ethics with a "patients first" value system.
Education and Professional Experience:
- Requires bachelor’s degree, preferably in a science related field
- The candidate must have a minimum 7 years of experience in the Biopharma industry preferably with experience in regulatory (Operations, CMC or Clinical Reg).
- Demonstrate ability to lead and work in a team environment to develop, implement and deliver on project goals.
- Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.
- PMP certification is highly desired.
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.
Travel: Travel is not frequently required (<5%)