Director, Regulatory Affairs

Great opportunity to join Parexel as a Director, Regulatory Affairs and use your regulatory expertise to lead a truly exceptional team!  

This position requires a seasoned professional with deep expertise in regulatory affairs, particularly in clinical-focused technical writing and FDA regulatory processes. The ideal candidate will possess exceptional leadership skills and demonstrate the ability to provide strategic oversight while offering hands-on support in developing and managing regulatory documentation for submissions. A keen balance between high-level strategic thinking and detail-oriented execution in regulatory writing is essential for success in this position.

You will:

• 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.

Skills:

• 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.

To ensure success, you will have:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD) Preferred

• 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

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