Manager - Regulatory Affairs Operations

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 responsabilities :

• 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 the responses to Health Authority inquiries and the preparation of the FDA Advisory Committee meetings (coordinating sub-team activities, arranging mock sessions [covering both 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 DBV's subject matter experts (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 associated 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 the biotech or pharmaceutical industry, with a focus on biologics, is strongly preferred.

• Proven experience in preparing and submitting Investigational New Drug (IND) amendments and meeting briefing documents.

• Experience with Biologics License Applications (BLA) is required.

• Must have and be able to apply in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format.
• Experience with European Union Marketing Authorization Applications (MAA) is preferred.

• Experience with FDA Advisory Committee meetings is preferred.

• Excellent project management and technical writing skills.

• Strong understanding of the scientific principles underlying drug and biologics development.

• Proficiency in working with Veeva RIM is a critical requirement and must be able to communicate effectively about its use including review tools and the ability to train others in using all the essential elements of this system including tracking of Regulatory commitments.

• Knowledgeable in International Conference on Harmonisation (ICH) guidelines and regulatory requirements from the FDA.

• Experience with Clinical Trial Applications (CTAs) in the US, Canada, the European Union, the UK, and Australia is a plus.

Behavioral skills :

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.

The compensation range for this role is 100-115K base - Bonus 15%