Position: Director, Regulatory Affairs
Overview: Join our team to provide technical and managerial leadership to various levels of resources through both direct and indirect reporting structures. This role is responsible for leading regulatory service projects by offering robust regulatory strategies, managing interactions with regulatory agencies, and preparing regulatory applications for various product types. It involves both strategic planning and tactical responsibilities.
Responsibilities:
- Lead external-facing project teams with accountability for project strategy, execution, success, and client satisfaction.
- Plan and execute regulatory activities, delegating and monitoring the quality and progress of work while providing technical support.
- Support business development efforts related to Regulatory Affairs, including presentations, public speaking, and contributions to publications.
- Lead and attend meetings with regulatory authorities and serve as the main point of contact.
- Manage regulatory application timelines and inform clients of regulatory risks.
- Work with eCTD publishing resources to ensure accurate linking and complete necessary forms for submissions.
- Maintain communication logs with regulatory authorities for client programs.
- Mentor and develop regulatory team members through cross-functional projects or direct management.
- Provide functional management and leadership of direct reports, including performance reviews, mentoring, and resource management.
- Support internal business initiatives to improve processes and practices.
- Ensure conformance to quality and external regulatory compliance standards.
- Prepare regulatory applications for authorities, including expedited pathway programs.
- Perform technical and regulatory reviews of source documents.
- Conduct due diligence reviews and inform executive counsel/investors of regulatory risks.
- Review and edit regulatory submissions, working with experts to ensure readiness.
- Provide subject matter expertise in all areas of Regulatory Affairs.
- Identify and interpret regulations and guidelines from relevant agencies.
- Compile and review information related to regulatory applications and inspections.
- Assess the regulatory impact of changes to on-market products.
Educational Background: An advanced degree in a scientific field is preferred.
Experience:
- 10+ years of regulatory experience in pharmaceuticals, biologics, or drug-device combination products (including education).
- 5+ years in a Regulatory Affairs leadership role.
- Recognized expert in regulatory strategy and pathway assessments.
- Successful track record of product approvals in global markets.
- Experience preparing regulatory applications for clinical and marketing authorization in the US and Europe, including authoring eCTD sections.
- Knowledge of ICH guidelines for nonclinical and clinical development.
Desired Skills:
- Detail-oriented with strong organizational and communication skills.
- Ability to thrive in a fast-paced, dynamic environment.
- Strong partnership skills with internal and external stakeholders.
- High emotional intelligence and technology-savvy.
Travel: Up to 20% travel may be required for client meetings, regulatory authority meetings, and related events. A passport is required.
