Director, Regulatory Affairs

6 days ago

Billerica MA United States Parexel International Corporation Full time

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


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