Senior Consultant / Regulatory Affairs Project Leader
Company: PAREXEL
Location: Hamilton
Posted on: February 25, 2021
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Job Description:
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.QualificationsSuccessful 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 to create 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
-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.
-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
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.
Keywords: PAREXEL, Hamilton , Senior Consultant / Regulatory Affairs Project Leader, Professions , Hamilton, Ohio
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