Regulatory Affairs Lead / Regulatory Affairs Project Manager

Parexel currently has an excellent opportunity for a Regulatory Affairs Project Lead/Manager with previous experience in Regulatory Affairs and past experience managing quality, on-time regulatory applications and filings to join Parexel’s incredible Regulatory Consulting Team! This home-based position is part of our highly recognized and growing Regulatory Consulting 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 Affairs Project Lead, 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.

QualificationsSuccessful candidates must at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at least 5+ years' experience working as a Regulatory Affairs Lead within a CRO (preferred), a Global Health Authority ie. the FDA, a Biotech or a Pharmaceutical Company.

Successful candidates will have:Past experience overseeing cross-functional teams and leading the creation of preINDs, INDs, NDAs, and/or BLAsExperience leading FDA meetings, gap analysis activities, and other ad hoc meetings as requiredPrevious US Agent experienceExcellent project management skills to include 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

•Consulting 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.

•Willingness to work in a matrix environment and to value the importance of teamwork.

•Experience with financials and managing project budgets

When appropriate. up to approximately 30% Domestic and/or International Travel may be requiredEEO DisclaimerParexel 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.