Associate Director, Regulatory Affairs - Combination Products

Regulatory Affairs United States Morrisville, North Carolina

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Description

Position at Kymanox

Is Kymanox the right fit for you? 
  
     You want to make a difference and have an impact… 
     You enjoy having an influence in your day-to-day work… 
     You are motivated by working alongside a team filled with 
                  subject matter experts who will help you learn and grow… 
     You wake up every day and do what you do 
            … because patients deserve better. 
  
If this sounds like you, you’ve come to the right place. 
  
The Associate Director, 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 Kymanox office, or remotely. 
  
Responsibilities: 

  • Provide 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.

  • Lead and attend meetings with regulatory authorities. Serve as the Regulatory Point of Contact to regulatory authorities, as requested by clients.

  • Prepare regulatory applications, including expedited pathway programs, for regulatory authorities on behalf of Kymanox 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.  

  • Perform technical and regulatory review of source documents.

  • 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. 

  • Perform due diligence reviews and inform executive counsel/investors of regulatory risks, as requested by clients.

  • 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 Kymanox processes and practices. Evaluate future business needs and derive/implement strategies to meet those needs.  

  • Support the efforts of the Kymanox 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.  

  • Ensure conformance to Kymanox quality and external regulatory compliance standards.

  • 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.

Educational Background: 
  • The ideal candidate will have an advanced degree in a scientific field.
Experience: 

  • 10+ years of regulatory experience in pharmaceuticals, biologics, and combination products (drug-device or biologic-device).

  • 5+ years in a Regulatory Affairs leadership role managing direct reports.

  • 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 relevant standards and guidance documents for medical devices, drugs, biologics, and combination products

Desired Aptitude and Skill Set: 

  • 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

Travel:   
 
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. 
  
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 functions within the organization.    
    
Compensation:     
 
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for incentive program after 90 days of outstanding work.      
   
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.      

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