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