Nuvalent, Inc. - Senior Manager, Regulatory Affairs
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Requirements
• 6-8 years of experience in Regulatory Affairs or combination of education and direct experience. • Bachelor or advanced degree in a scientific field or equivalent work experience is required. Master’s degree a plus. • Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes. • Solid understanding of the e-CTD specifications for electronic submissions. • Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD and CDER requirements for the drug approval process. • Previous participation in preparing and/or leading regulatory submissions (IND, CTA, NDA, etc.). Experience with preparing meeting packages is a plus. • Experience in interpretation of regulations, guidelines and precedents related to drug development in the US and EU. • Strong understanding of regulatory eCTD structure and clinical trial conduct and design • Proficiency with electronic submission publishing software and document management information systems (i.e., docuBridge, Veeva Vault RIM) • Ability to plan, prioritize and contribute to work and projects in a systematic and efficient manner with emphasis on streamlining processes • Additional Information:
Responsibilities
• Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved • As part of the regulatory clinical study team, you will support preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.) • Provide regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning) • Ensure collaboration with and coordination of cross-functional project teams for timely execution of regulatory submissions, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight • Support regulatory operations during the regulatory submissions handoff process, as the primary point of contact for external publishing vendors, ensuring submission packages are accurate, formatted correctly, and validated. • Maintain the regulatory information system and ensure proper archiving, searchability, and accessibility of regulatory content including correspondence with regulatory agencies • Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate • Ensure compliance with internal SOPs, regulations and applicable laws. Drafts and reviews Regulatory Affairs SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required • Competencies Include: • Excellent attention to detail and ability to complete efficient and detailed technical data review • Excellent organization, communication, and multi-tasking skills • Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships • Strong desire to contribute as a member of an engaged and collaborative cross-functional project development team
Benefits
• $160,000—$185,000 USD • Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. • Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities. • Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person. • If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
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