Senior Scientist, Regulatory Strategy

Kymanox

About The Position

Kymanox is seeking a Senior Scientist, Regulatory Strategy to join their team. This role is for individuals who want to make a difference, have an impact, enjoy influencing their day-to-day work, and are motivated by working alongside subject matter experts. The core mission is driven by the belief that patients deserve better. The position offers opportunities for learning and growth within a dynamic, fast-paced, and growing company that provides life sciences professional services. Kymanox is a life sciences professional services company that has successfully delivered over 4000 projects across 20+ countries. They help a broad range of life science products get to market more quickly, affordably, and with the highest quality and safety standards. The company specializes in engineering, compliance, and project management services for clients ranging from Fortune 100 companies to virtual start-ups. Founded in 2004 and headquartered in Research Triangle Park, NC, Kymanox offers an outstanding opportunity for learning and career advancement.

Requirements

5+ years’ regulatory experience in the US medical device, pharmaceutical, or combination productions industry (this includes post graduate experience).
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.

Nice To Haves

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

Responsibilities

Assist with US and EU regulatory submissions (IND/NDA/BLA/510(M)/PMA/technical documentation/MAA/IMPD), meeting briefing books, clinical trial applications, and other submissions for regulatory authorities under the guidance of a Regulatory Strategy Lead.
Attends and supports meetings with regulatory authorities.
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 a 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 and risk trackers in accordance with client expectations and regulatory authority requirements. Informs 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.
Completes assigned training requirements (internal and external).