Principal Regulatory Affairs Advisor

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. Reporting to the Director of Regulatory Affairs, the Principal Regulatory Affairs Advisor will deliver Regulatory Affairs services by supporting the development of robust regulatory strategies and preparing regulatory applications covering drug products, biologics, and combination products. This person will work directly with clients and with project team members. This position involves regulatory strategy research, project planning, as well as hands-on responsibilities.       Responsibilities:

• Supports the Regulatory Strategy Lead by performing regulatory research and development of regulatory assessments. 
• Supports the Regulatory Lead in interactions with regulatory authorities.
• Authors and manages regulatory submissions through the product lifecycle from concept to post-market for drugs, biologics, and combination products (INDs/CTAs/NDA/BLA/RFD/Orphan Designation/Fast Track/PAS, etc.), and meeting documents with regulatory authorities on behalf of clients. Manages cross-functional team members to contribute required information to complete submissions.
• Manages regulatory application timelines in accordance with client expectations and regulatory authority requirements. 
• Works directly with regulatory application publishing service providers to ensure accurate linking and completes necessary forms required for submission to regulatory authorities.
• Performs IND maintenance activities.   
• Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory authorities.  
• Mentors project team members with less experience as part of project execution. 

Educational Background:Undergraduate and advanced degree in an engineering or scientific discipline from an accredited institution. Relevant industry certifications (e.g., RAC) are desired.         Experience:Doctoral degree and 5+ years OR Master’s degree and 8+ years of proven experience, including significant time spent performing regulatory activities for pharmaceuticals and/or biologics in the United States. Experience in other global markets is desirable, but not required. Ideal candidates will demonstrate a career focus and expertise in many of the following knowledge areas:          

• Development of regulatory strategy for complex products, including drug/biologic-device combination products.
• Experience in nonclinical and/or clinical aspects of drug development programs.
• Knowledge of bridging strategies for leveraging literature or prior studies for approved products.
• Regulatory body meeting preparation and facilitation.
• Regulatory submission authorship and review.
• Regulatory body information request responses.
• Expedited pathway applications.
• Pediatric study plans.

Ideal candidates will demonstrate a mix of past proven experience in both large and small operating companies, in roles spanning multiple disciplines with evolving levels of responsibility.     Desired Aptitude and Skill Set:

• Ability to balance leading several high-profile projects at one time.
• 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 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.
• Self-motivated and able to influence others to drive team and project success.
• Uncompromised honesty and integrity.

 Travel:  Up to 10% travel is possible for support at meetings with health authorities. 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 –