Principal Scientist, Regulatory Strategy

Responsibilities

• Serve as Technical Lead by guiding US and EU regulatory submissions (IND/NDA/BLA/IDE/510(k)/PMA/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.

Requirements

• The ideal candidate will have a bachelor’s and/or master’s degree in an engineering or scientific discipline from an accredited institution.
• 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.

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 (i.e., 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