Parexel currently has an excellent opportunity for a Regulatory Project Leader/Senior Consultant with previous experience in Regulatory Affairs and past experience managing quality, on-time regulatory applications and filings. This Regionally Home Based position is part of our growing Regulatory Consulting Services Team and offers an amazing opportunity to join an industry leader in a field that continues to see tremendous growth and opportunity!
As a Regulatory Project Leader you will provide leadership to project teams and manage the day to day operations of domestic and international Regulatory projects. You will strive to achieve operational excellence through on time delivery that is within budget and to the highest quality with the goal to exceed client expectations.
Successful candidates must at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at least 10+ years' experience working as a Regulatory Project Leader/Manager within a CRO (preferred), a Global Health Authority ie. the FDA, a Biotech or a Pharmaceutical Company. Past experience overseeing a cross-functional team involved in the creation of US Regulatory Submissions to include preINDs, INDs, NDAs, and/or BLAs is required.
This position also requires experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience in Regulatory Affairs related activities.
Successful candidates must also possess the following:
The ability to build and sustain relationships
Critical thinking and problem solving
The ability to influence and lead teams
Financial management skills
Strategic thinking skills
Attention to detail and commitment to quality
Conflict management skills
Contingency planning and risk management skills
People management skills
Excellent interpersonal, verbal and written communication skills
Client focused approach to work
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Proficient in local language where appropriate and profound working knowledge of the English language
Proficient in Microsoft Excel, Power Point, MS Project and Word.
Experience with Parexel systems is a plus
Willingness to work in a matrix environment and to value the importance of teamwork.
Experience with financials and managing project budgets
Up to approximately 30% Domestic and/or International Travel may be required
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.