DBV Technologies
Description :
We are seeking a detail-oriented and proactive Manager to join our Regulatory Affairs Operations team. In this role, you will collaborate with regulatory and cross-functional teams to prepare and submit regulatory filings, including major U.S. marketing applications. Your responsibilities will encompass developing submission plans, managing timelines, and ensuring timely and compliant regulatory submissions. A pivotal aspect of this position involves leading the strategic planning of the U.S. Biologics License Application (BLA) preparation and defense, as well as coordinating activities related to FDA Advisory Committee (AdComm) meeting preparation. Location : Warren, NJ Hybrid - On site 3 days a week Key responsibilities:
Project Management : Lead the development and execution of project timelines, ensuring the timely preparation and submission of regulatory documents in compliance with submission plans and regulatory standards. Collaborate with cross-functional teams to create and maintain a comprehensive Global Submission Plan, detailing dossier content, key activities, timelines, and projected approval dates. Conduct scenario planning to evaluate multiple regulatory strategies and recommend approaches to expedite timelines when necessary. Additionally, oversee and update the Regulatory Affairs IND submission log to ensure accurate tracking and prompt execution of submissions. Regulatory Submissions Coordination : Lead the preparation and submission of regulatory applications such as BLAs, INDs, and responses to Health Authority inquiries, working closely with cross-functional stakeholders including CMC, Non-Clinical, Clinical, and Labeling teams. Support Major Marketing Application (BLA) preparation, submission, and defense : Assist the regulatory team in the preparation, coordination, electronic publishing, and quality control (QC) of the BLA. Ensure that all components adhere to regulatory standards and are submitted within established timelines. Assist in the planning, coordination, and tracking of all activities related to BLA preparation, ensuring alignment across teams and internal milestones. Provide support and coordination for post-submission activities essential to the approval process. This includes the coordination of responses to Health Authority inquiries and the preparation of FDA Advisory Committee meetings (coordinating sub-team activities, arranging mock sessions covering logistics and content, and managing key deliverables). ePublishing Coordination : Coordinates submission publishing activities with e-publishing vendor for all BLA/IND deliverables. RIMS Oversight : Manage all aspects of regulatory submission preparation and archiving within the Regulatory Information Management System (RIMS). Provide guidance and support to SMEs in effectively navigating and utilizing the RIM system. Regulatory Intelligence : Monitor regulatory changes and competitor activities regarding e-Publishing requirements, assessing their potential impact on ongoing projects and strategies. Contract Management : Support the management of contracts with third parties, including the creation and monitoring of purchase orders. Qualifications:
Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required; an advanced degree (PhD, PharmD, MS) is strongly preferred. Minimum of 2 years of regulatory experience in biotech or pharmaceutical industry, focusing on biologics, is strongly preferred. Proven experience in preparing and submitting IND amendments and briefing documents. Experience with Biologics License Applications (BLA) is required. Deep knowledge of global regulatory submission requirements, processes, and eCTD structure/format. Experience with European MAA is preferred. Experience with FDA Advisory Committee meetings is preferred. Excellent project management and technical writing skills. Strong understanding of drug and biologics development principles. Proficiency with Veeva RIM, including training others and managing regulatory commitments. Knowledge of ICH guidelines and FDA regulatory requirements. Experience with Clinical Trial Applications (CTAs) in various regions is a plus. Behavioral skills : Curiosity: Explore uncharted territories, ask “why?” and “why not?” Courage: Take smart risks, mentor, and be accountable. Collaboration: Support teamwork and shared goals. Credibility: Be transparent, follow through, and build trust. The compensation range for this role is $100K-$115K base + 15% bonus.
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We are seeking a detail-oriented and proactive Manager to join our Regulatory Affairs Operations team. In this role, you will collaborate with regulatory and cross-functional teams to prepare and submit regulatory filings, including major U.S. marketing applications. Your responsibilities will encompass developing submission plans, managing timelines, and ensuring timely and compliant regulatory submissions. A pivotal aspect of this position involves leading the strategic planning of the U.S. Biologics License Application (BLA) preparation and defense, as well as coordinating activities related to FDA Advisory Committee (AdComm) meeting preparation. Location : Warren, NJ Hybrid - On site 3 days a week Key responsibilities:
Project Management : Lead the development and execution of project timelines, ensuring the timely preparation and submission of regulatory documents in compliance with submission plans and regulatory standards. Collaborate with cross-functional teams to create and maintain a comprehensive Global Submission Plan, detailing dossier content, key activities, timelines, and projected approval dates. Conduct scenario planning to evaluate multiple regulatory strategies and recommend approaches to expedite timelines when necessary. Additionally, oversee and update the Regulatory Affairs IND submission log to ensure accurate tracking and prompt execution of submissions. Regulatory Submissions Coordination : Lead the preparation and submission of regulatory applications such as BLAs, INDs, and responses to Health Authority inquiries, working closely with cross-functional stakeholders including CMC, Non-Clinical, Clinical, and Labeling teams. Support Major Marketing Application (BLA) preparation, submission, and defense : Assist the regulatory team in the preparation, coordination, electronic publishing, and quality control (QC) of the BLA. Ensure that all components adhere to regulatory standards and are submitted within established timelines. Assist in the planning, coordination, and tracking of all activities related to BLA preparation, ensuring alignment across teams and internal milestones. Provide support and coordination for post-submission activities essential to the approval process. This includes the coordination of responses to Health Authority inquiries and the preparation of FDA Advisory Committee meetings (coordinating sub-team activities, arranging mock sessions covering logistics and content, and managing key deliverables). ePublishing Coordination : Coordinates submission publishing activities with e-publishing vendor for all BLA/IND deliverables. RIMS Oversight : Manage all aspects of regulatory submission preparation and archiving within the Regulatory Information Management System (RIMS). Provide guidance and support to SMEs in effectively navigating and utilizing the RIM system. Regulatory Intelligence : Monitor regulatory changes and competitor activities regarding e-Publishing requirements, assessing their potential impact on ongoing projects and strategies. Contract Management : Support the management of contracts with third parties, including the creation and monitoring of purchase orders. Qualifications:
Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required; an advanced degree (PhD, PharmD, MS) is strongly preferred. Minimum of 2 years of regulatory experience in biotech or pharmaceutical industry, focusing on biologics, is strongly preferred. Proven experience in preparing and submitting IND amendments and briefing documents. Experience with Biologics License Applications (BLA) is required. Deep knowledge of global regulatory submission requirements, processes, and eCTD structure/format. Experience with European MAA is preferred. Experience with FDA Advisory Committee meetings is preferred. Excellent project management and technical writing skills. Strong understanding of drug and biologics development principles. Proficiency with Veeva RIM, including training others and managing regulatory commitments. Knowledge of ICH guidelines and FDA regulatory requirements. Experience with Clinical Trial Applications (CTAs) in various regions is a plus. Behavioral skills : Curiosity: Explore uncharted territories, ask “why?” and “why not?” Courage: Take smart risks, mentor, and be accountable. Collaboration: Support teamwork and shared goals. Credibility: Be transparent, follow through, and build trust. The compensation range for this role is $100K-$115K base + 15% bonus.
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