Director, Regulatory Affairs -FDA

Raleigh, North Carolina, United States | Nate Blazei | Full-time

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Kymanox has an exciting leadership opportunity available at a Director level.

 The Director is expected to provide both technical leadership and managerial leadership to permanent and contract staff, through both direct and indirect reporting structures. Successful candidates will have measurable experience in people leadership, mentorship, and development.

The ideal candidate will possess a strong foundation in Regulatory Affairs for product development and commercialization in the United States, Europe, and other global regions, including expertise in the following knowledge areas:

· Regulatory strategy for biopharmaceuticals, drugs, and combination products

· Regulatory submission authorship and review (clinical and commercial stage)

· Regulatory body meeting preparation and facilitation

· Regulatory body information request responses

· Technical document authorship and review

· Auditing and gap assessments

 

Ideal candidates will demonstrate a mix of past proven experience in both large and small operating companies or professional service providers with increasing levels of responsibility.

Detailed Description of Typical Duties:

· Provide senior leadership to external-facing Kymanox 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 the Business Development and Marketing teams as it relates to Regulatory Affairs, including presentations to prospective clients, public speaking engagements (i.e., conferences), and contributions to industry publications.

· Provide mentorship and development opportunities to the Regulatory Affairs team as part of cross-functional projects or as direct reports.

· Responsible for team performance reviews and evaluations, mentoring and coaching, resource management, goal setting, time tracking and reporting.

· Evaluate candidates for hire to grow the Regulatory Affairs team.

· Support internal business initiatives to improve Kymanox processes and practices.

· Ensure conformance to Kymanox quality and external regulatory compliance standards, thereby fostering a positive compliance culture.

· Prepare regulatory submissions (IND/NDA/BLA/MAA/CTA ) and annual reports for regulatory authorities on behalf of Kymanox clients.

· Perform technical and regulatory review of source documents.

· Create and/or review dossiers, briefing books, and responses to regulatory body questions; work with experts and authors to prepare information for submissions and ensure submission readiness.

· Conduct audits/gap assessments of regulatory submissions, design history files, risk management files, and technical documentation against industry regulations and standards (US/EU/ROW).

· Directly support and provide subject matter expertise related to all disciplines of Regulatory Affairs, but not limited to, complaints handling and adverse event reporting, design controls, risk management, and labeling.

· Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies and other industry organizations.

· Review combination product development process documentation including user requirements, technical design requirements, product risk management documents (including risk assessments, risk management reports), verification and validation test protocols; and communicate any regulatory-specific red flags during review.

· Provide assessment of regulatory impact of changes to marketed products.

 

Educational Background:

Undergraduate and advanced degree in engineering, science, or Regulatory Affairs from an accredited institution. Relevant industry certifications (e.g., RAC) are desired.

Experience:

Doctoral degree and 10+ years OR Master’s degree and 15+ years of proven experience, including 8+ years of Regulatory Affairs experience minimally in US/EU for biopharmaceuticals and combination products.

Desired Aptitude and Skill Set:

· Ability to balance leading high-profile projects while managing, coaching, and mentoring internal team.

· As a leader, understands accountability for failures and successes. Comfortable providing both positive and negative feedback to team members as appropriate.

· Confidence in managing client stakeholders within small, medium, and large companies, including communications with client executive leadership.

· Extremely detail-oriented and highly organized.

· “Proactive” vs. “reactive” management of people and projects.

· Strong professional presence and presentation skills.

· Excellent written and oral English communication skills.

· Flexible and willing to branch out beyond immediate areas of expertise.

· Demonstrated professional maturity and emotional intelligence (EQ).

· Self-motivated and able to influence others to drive team and project success.

· Uncompromised honesty and integrity. 

Location: Research Triangle Park, NC, USA

Travel:

Up to 25% travel domestically and internationally (following government guidelines for the pandemic) is possible. A passport is required for this position.

Career Development:

The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other groups within the organization.

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.