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

#LI-LB1

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.