The Director of Regulatory Affairs will join our team and play a key role in providing both technical and managerial leadership to principal, senior, and associate level resources through both direct and indirect reporting structure. This role will also be responsible for leading regulatory service projects by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory applications for drug products, biologics, medical devices, and combination products. This position involves high-level strategic planning as well as tactical responsibilities. Services may be provided at a client site, from a company office, or remotely.
The Director of Regulatory Affairs is a full-time, hybrid position based in Morrisville, NC. Up to 20% travel is possible for support at client meetings, regulatory authority meetings, tradeshows, conferences, and related events. A passport is required for this job.
Responsibilities of the Director of Regulatory Affairs:
- Provide leadership to external-facing project teams with accountability for project strategy, execution, success, and client satisfaction.
- Lead planning and execution of regulatory activities. Delegate and monitor quality and progress of work, providing technical support and direction to project teams.
- Support the efforts of Business Development and Marketing teams as it relates to Regulatory Affairs, including presentations to prospective clients, public speaking engagements (i.e., conferences, industry events), and contributions to industry publications.
- Lead and attend meetings with regulatory authorities. Serve as the Regulatory Point of Contact to regulatory authorities, as requested by clients.
- Manage regulatory application timelines in accordance with client expectations and regulatory authority requirements. Inform clients of regulatory risks.
- Work directly with eCTD publishing resources to ensure accurate linking; complete necessary forms required for application submissions.
- Manage application communication logs with regulatory authorities for client programs.
- Provide mentorship and development opportunities to regulatory team, as part of cross-functional projects or as direct reports.
- Provide functional management and leadership of direct reports within team.
- Responsible for team performance reviews and evaluations, mentoring and coaching, resource management, goal setting, and time tracking and reporting.
- Support internal business initiatives to improve processes and practices. Evaluate future business needs and derive/implement strategies to meet those needs.
- Ensure conformance to quality and external regulatory compliance standards.
- Prepare regulatory applications, including expedited pathway programs, for regulatory authorities on behalf of the company’s clients.
- Perform technical and regulatory review of source documents.
- Perform due diligence reviews and inform executive counsel/investors of regulatory risks, as requested by clients.
- Review and edit dossiers, briefing books, and responses to regulatory authority questions; work with experts and authors to prepare information for regulatory applications and ensure submission readiness.
- Directly support and provide subject matter expertise related to all disciplines of Regulatory Affairs.
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Compile and review information relating to regulatory applications, inspections, or response letters to regulatory bodies.
- Provide assessment of regulatory impact of changes to on-market products.
Qualifications of the Director of Regulatory Affairs:
- Advanced degree in a scientific field.
- 10+ years of regulatory experience in pharmaceuticals, biologics, or drug-device combination products (this includes educational experience toward advanced degree).
- 5+ years in a Regulatory Affairs leadership role.
- Recognized subject matter expert for regulatory strategy and pathway assessments.
- Successful track record of product approvals in different global markets.
- Demonstrated experience preparing regulatory applications for clinical and marketing authorization in the US and Europe/United Kingdom, including authoring of eCTD sections and publishing.
- Working knowledge of ICH guidelines for nonclinical development, clinical development, and pharmaceutical quality requirements.
- Detail-oriented
- Strong organizational skills and verbal/written communication skills
- Thrives in a fast-paced, growing, and dynamic work environment
- Ability to form partnerships with internal and external stakeholders
- Seasoned soft skills (i.e., high EQ)
- Technology savvy
Contact Judy Protz at jprotz@hirenetworks.com with questions regarding this posting. A Word resume is preferred when applying.
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