Senior Scientist, Regulatory Strategy

Responsibilities

• Aid in 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.
• Attend and support meetings with regulatory authorities.
• Perform technical and regulatory reviews of source documents, clinical/nonclinical data, design development files, and regulatory submissions against industry regulations and standards (US/EU/ROW).
• Review and edit dossiers, briefing books, and responses to health authority questions; work with SMEs and authors to prepare information for submissions and ensure submission readiness.
• Develop 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.
• Participate in cross-functional development teams as a regulatory SME for large-scale projects.
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Manage regulatory submission timelines and risk trackers in accordance with client expectations and regulatory authority requirements.
• Inform clients of regulatory risks.
• Work directly with eCTD publishing to ensure accurate linking; complete necessary forms required for submissions.
• Manage IND and NDA communication logs with regulatory authorities for client programs.
• Complete assigned training requirements (internal and external).

Requirements

• The ideal candidate will have a bachelor’s and/or master's degree in Regulatory Affairs or a science-related field.
• 5+ years’ regulatory experience in the US medical device, pharmaceutical, or combination productions industry (includes post-graduate experience).
• Demonstrated experience of preparing US FDA/EU EMA submissions (e.g., 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.

Qualifications

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

Benefits

• Medical healthcare including dental and vision.
• Short- and long-term disability.
• Life insurance.
• Matching 401(k) retirement plan.
• Continuing education assistance.
• Other benefits.

About Kymanox

Kymanox is a life sciences professional services company dedicated to helping life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible. Founded in 2004, Kymanox has grown steadily since its inception and provides professional services related to engineering, compliance, and project management. The company services clients ranging from Fortune 100 companies to virtual start-up companies and is headquartered in Research Triangle Park, NC.