Director, Regulatory Affairs
Director, Regulatory Affairs
myGwork - LGBTQ+ Business Community
United States
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This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.
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
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.
- 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.
- 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
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Legal -
Industries
Pharmaceutical Manufacturing
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