Parexel · 4 days ago
Director, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
10+ years exp
Maximize your interview chancesPharmaceuticals
Hiring Manager
Lisa B.
Insider Connection @Parexel
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Responsibilities
Use your extensive Regulatory and Product Development clinical and non-clinical strategy experience for all phases applications in the US.
Lead a team of Regulatory Affairs professionals, focusing on technical writing skills and high-quality clinical/non-clinical document development for submissions.
Provide strategic guidance on crafting compelling regulatory documents for submissions
Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on regulatory guidelines and requirements.
Interact with various stakeholders around the world, including the writing team, subject matter experts, project leadership, and the Sponsor with a focus on high-quality deliverables.
Create efficient workflows, timelines, and demonstrate strong project management skills for timely, high-quality deliverables.
Facilitate effective coordination and communication among stakeholders to achieve project goals.
Collaborate with cross-functional teams to ensure alignment of regulatory strategy with overall product development goals.
Implement strategies to mitigate risks and address potential challenges in project execution and staff allocation, resourcing needs.
Facilitate staff development plans and coordinates with project staffing for appropriate utilization and skill expansion.
Participate in project scoping calls, proposal preparation, Bid Defense Meetings, and account planning/oversight for key clients.
Actively prospect and leverages new business opportunities in collaboration with Account Management
Communicate organizational vision and values to staff and promotes effective information flow.
Qualification
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Required
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
10-15 years related Regulatory Affairs experience in the life sciences or consulting industries
8+ years of experience in people management and leadership experience within the clinical and/or nonclinical regulatory functions
Deep expertise in regulatory affairs, particularly in clinical-focused technical writing and FDA regulatory processes
Exceptional leadership skills
Ability to provide strategic oversight while offering hands-on support in developing and managing regulatory documentation for submissions
Extensive Regulatory and Product Development clinical and non-clinical strategy experience for all phases applications in the US
Experience leading a team of Regulatory Affairs professionals, focusing on technical writing skills and high-quality clinical/non-clinical document development for submissions
Expertise in interactions with regulatory agencies (such as FDA) and provides expertise on regulatory guidelines and requirements
Ability to interact with various stakeholders around the world, including the writing team, subject matter experts, project leadership, and the Sponsor with a focus on high-quality deliverables
Ability to create efficient workflows, timelines, and demonstrate strong project management skills for timely, high-quality deliverables
Facilitate effective coordination and communication among stakeholders to achieve project goals
Collaborate with cross-functional teams to ensure alignment of regulatory strategy with overall product development goals
Implement strategies to mitigate risks and address potential challenges in project execution and staff allocation, resourcing needs
Facilitate staff development plans and coordinates with project staffing for appropriate utilization and skill expansion
Participate in project scoping calls, proposal preparation, Bid Defense Meetings, and account planning/oversight for key clients
Actively prospect and leverages new business opportunities in collaboration with Account Management
Communicate organizational vision and values to staff and promotes effective information flow
Management and leadership skills with proven experience coaching, motivating, developing, and retaining high performing regulatory professionals
Consulting skills
Project management knowledge
Influencing others
Client-focused approach to work
Networking
Results orientation
Business analysis
Excellent interpersonal and intercultural communication skills, both written and verbal
Teamwork and collaboration
Critical thinking and problem-solving skills
Holding people accountable
Operational leadership
Leading change
Strategic business thinking
Strong organization and planning skills with an attention to detail and ability to handle multiple tasks with accuracy
Preferred
Advanced Degree (MSc, PhD)
Previous CRO or Consulting experience highly preferred
Company
Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Amy France
SVP, CFO - Consulting & Commercial
Carlos Daniel Garcia
VP Chief Financial Officer - Medical Scientific Services Business Unit
Recent News
2024-04-27
2024-04-07
Company data provided by crunchbase
