Principal Scientist, Regulatory Strategy

Kymanox

About The Position

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 submissions—including INDs, NDAs, BLAs, IDEs, 510(k)s, PMAs, technical documentation, MAAs, and IMPDs—while guiding cross‑functional teams to ensure high‑quality, 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 large‑scale development programs as the regulatory SME, ensuring alignment between regulatory requirements, program objectives, and client expectations.

Requirements

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.

Nice To Haves

Prior experience with combination products and/or biologics preferred.

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.