Consultant Regulatory Affairs Roles - REMOTE job in Austin, USA

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First Name*

Last Name*

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Job type: Permanent

Discipline: Consultant / Specialist, Publishing & Submissions, Operations

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote Consultant Regulatory Affairs Roles at a global clinical research organization. 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!

Job Responsibilities:

Provide leadership to project teams
Manage the day to day operations of domestic and international Regulatory projects
Achieve operational excellence through on time delivery that is within budget and to the highest quality with the goal to exceed client expectations.

Skills and Requirements:

Candidates must at minimum, possess an undergraduate degree in a clinical or health related field, advanced degree preferred
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.
Experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience in Regulatory Affairs related activities.
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

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at 424-361-3900 x3900 or f.gbadamosi@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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