Project Manager, Regulatory Affairs

Regulatory Affairs Thousand Oaks, California

Position Summary

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:  Senior Manager, Regulatory Project Manager

Location:  Thousand Oaks, CA

Primary Responsibilities:

  • 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.

 

Physical Requirements:

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%)