Principal Regulatory Affairs Engineer/Scientist
Description
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 that 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 Engineer/Scientist will deliver Regulatory Affairs services by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory applications covering drug products, biologics, and combination products. This person will be supported by experienced technical project managers and subject matter experts across all disciplines while working directly with clients. This position involves high-level strategic planning as well as hands-on responsibilities.
Detailed Description of Typical Duties:
- Provides technical leadership to client projects in areas of subject matter expertise.
- Attends meetings with regulatory authorities. May serve as the Regulatory Point of Contact to regulatory authorities, as requested by clients.
- Authors clinical and marketing applications, including expedited pathway applications, and briefing documents on behalf of clients.
- Manages regulatory application timelines in accordance with client expectations and regulatory authority requirements. Informs clients of regulatory risks.
- Works directly with regulatory application publishing service providers to ensure accurate linking and completes necessary forms required for submission to regulatory authorities.
- Manages communication logs with regulatory authorities for client programs.
- Performs technical and regulatory review of source documents.
- Performs searches and review of relevant regulatory documentation to support regulatory strategy and assessments.
- Provides regulatory review of product development documentation from discovery/feasibility through the post-market phase.
- 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 10+ years OR Master’s degree and 13+ years of proven experience, including significant time spent performing regulatory activities for pharmaceuticals and/or biologics in the United States or European markets.
Ideal candidates will demonstrate a career focus and expertise in many of the following knowledge areas:
- Definition of regulatory strategy and pathway options for complex products, including drug/biologic-device combination products
- Deep understanding of nonclinical and 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
- Safety reporting and related pharmacovigilance activities
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 20% travel domestically and internationally 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 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.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.