Principal Scientist, Regulatory Strategy

I s 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, youve come to the right place. The Principal Scientist, Regulatory Strategy will serve as a senior member of our Development and Regulatory Strategy team, with leadership of FDA meetings as a core responsibility. You will prepare briefing packages, shape meeting strategy, and serve as the primary Regulatory Point of Contact during agency interactions. In this role, you will act as the Technical Lead for major U.S. and global submissionsincluding INDs, NDAs, BLAs, IDEs, 510(k)s, PMAs, technical documentation, MAAs, and IMPDswhile guiding crossfunctional teams to ensure highquality, compliant deliverables. You will review and interpret clinical, nonclinical, and technical data; develop regulatory roadmaps and strategic assessments; manage submission timelines; and advise clients on regulatory risks and pathways. As a Principal Scientist, you will also support largescale development programs as the regulatory SME, ensuring alignment between regulatory requirements, program objectives, and client expectations. Responsibilities:

• Serve as Technical Lead by guiding US and EU regulatory submissions (IND/NDA/BLA/IDE/510k/PMA/technical documentation/MAA/IMPD), meeting briefing books, clinical trial applications, and other submissions for regulatory authorities.
• Leads and attends meetings with regulatory authorities. Serves as the Regulatory Point of Contact to FDA, as requested by clients.
• Performs technical and regulatory review of source documents, clinical/nonclinical data, design development files, and regulatory submissions against industry regulations and standards (US/EU/ROW).
• Reviews and edits dossiers, briefing books, and responses to health authority questions; works with SMEs and authors to prepare information for submissions and ensure submission readiness.
• Develops early-stage development roadmaps and strategic regulatory assessments that guide regulatory strategy, working with Regulatory Strategy Leads, to support the project team and inform client decisions.
• Participates in cross-functional development teams as regulatory SME for large-scale projects.
• Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Manages regulatory submission timelines in accordance with client expectations and regulatory authority requirements. Inform clients of regulatory risks.
• Works directly with eCTD publishing to ensure accurate linking; completes necessary forms required for submissions.
• Manages IND and NDA communication logs with regulatory authorities for client programs.
• Provides assessment of regulatory impact of changes to on market products.

Educational Background:

• The ideal candidate will have a bachelors and/or masters degree in an engineering or scientific discipline from an accredited institution.

Experience:

• 7+ years regulatory experience in the US medical device, pharmaceutical, or combination products industry (this includes post graduate experience).
• 2+ years in a leadership role.
• Demonstrated experience of preparing US FDA/EU EMA submissions (eg, IND/NDA/IDE/510(k)/PMA/BLA/MAA/IMPD), including eCTD sections and publishing.
• Working knowledge of Quality System requirements (FDA Part 820, Parts 210/211, Part 4, and ISO 13485).
• Working knowledge of FDA guidance and ICH guidelines for CTD, GMPs, Good Clinical Practice (ICH E6), nonclinical and pharmaceutical quality requirements.
• Working knowledge of design controls (FDA 21 CFR 820.30).
• Working knowledge of device risk management (ISO 14971).
• Working knowledge of EU medical device and medicinal product regulations.
• Prior experience with combination products and/or biologics preferred.

Desired Aptitude and Skill Set:

• Detail-oriented
• Strong organizational skills and verbal/written communication skills
• Highly motivated self-starter with a sense of ownership and willingness to learn
• Thrive in a fast-paced, growing, and dynamic work environment
• Ability to form partnerships with internal stakeholders
• Seasoned soft skills (i.e., high EQ)
• Technology savvy

Travel: Up to 10% travel is possible. 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 6 months 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. About Kymanox: Join Kymanox a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in todays biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanoxs service offerings and the life science industry as a whole. Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC. To learn more about our company, please visit our website: Life Science Solutions | Kymanox 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.