Director, Regulatory Affairs

Great opportunity to use your regulatory expertise and lead a truly exceptional team!  

As a Director, Regulatory Affairs, you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships. 

You will:

• 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) and provides expertise on regulatory guidelines and requirements.

• Interact with various stakeholders, including the writing team, subject matter experts, project leadership, and the Sponsor with a focus on high-quality deliverables.   

• Assist your team, as needed, 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.

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

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.