Project Manager, Regulatory Affairs
San Rafael, California | Contract
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- Our Regulatory Affairs organization, made up of a team of over 70 dedicated professionals, continues to grow.
- If you are an experienced Project Manager with knowledge of drug development, interested in working in an environment where you' ll have the resources and infrastructure to tangibly impact patient' s lives, we want to talk with you.
- Manage Regulatory Sub-team operations, including facilitation of Subteam and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required).
- Create and maintain Regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management.
- Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
- Document project milestones/deliverables and report progress against team, department, and corporate goals.
- Facilitate short and long-term planning activities.
- Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement.
- Coordination across multiple departments: Clinical Science, Development PM, PharmSci, Manufacturing, Biostats.
- Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Uses professional concepts and company' s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
- At least 5 years' experience in a project management or scheduling environment; a minimum of two years' experience managing teams and team operations.
- Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology.
- MS Project Server experience helpful.
- Pharma/biotech or related industry experience required.
- Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.
- Knowledge of Regulatory Affairs submissions and nomenclature desirable.
- Exposure to electronic document management system(s) (EDMS) helpful.
- Bachelor's degree required.
- Project Management Professional and/or Regulatory Affairs Certification a plus.