Director, Regulatory Affairs

September 15

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Foster professional growth and development for your direct reports. • Use your extensive Regulatory and product development clinical and non-clinical strategy experience for all phases applications in the US and Canada. • Provide expertise in interactions with regulatory agencies (such as FDA). • Assist your team in the development of regulatory submission strategies. • Utilize expertise to create efficient workflows and timelines. • Provide support to your team and utilize your expertise in regulatory writing to produce high-quality documentation for regulatory submissions. • Ensure high-quality deliverables by coordinating with the writing team, subject matter experts, project leadership and Sponsor. • Demonstrate strong project management skills to ensure on-time and high-quality project delivery. • Facilitate effective coordination and communication between 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, and account planning 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.

Requirements

• 10-15 years related Regulatory Affairs experience in the life sciences or consulting industries. • Previous CRO or Consulting experience highly preferred • 8+ years of experience in people management and leadership experience within the clinical and/or nonclinical regulatory functions.