Associate Director -Regulatory Affairs Operations

Role Summary

Detail-oriented Regulatory Affairs Operations professional to join our team. Proficient with Veeva RIM is required. You will collaborate with regulatory and cross-functional teams to prepare and submit regulatory filings, including major U.S. marketing applications, and manage submission plans and timelines. You will lead the strategic planning of the U.S. BLA preparation and defense and coordinate FDA Advisory Committee meeting preparation, with hybrid on-site work in Warren, NJ.

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 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, including the coordination of responses to Health Authority inquiries and the preparation of FDA Advisory Committee meetings (coordinating sub-team activities, arranging mock sessions, 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 associated purchase orders.

Qualifications

• Required: Experience with Biologics License Applications (BLA).
• Required: In-depth knowledge of global regulatory submission requirements, processes and procedures, and eCTD structure/format.
• Preferred: EU Marketing Authorization Applications (MAA).
• Preferred: Experience with FDA Advisory Committee meetings.
• Required: Excellent project management and technical writing skills.
• Required: Strong understanding of the scientific principles underlying drug and biologics development.
• Required: Knowledge of ICH guidelines and FDA regulatory requirements.
• Preferred: Experience with Clinical Trial Applications (CTAs) in the US, Canada, the European Union, the UK, and Australia.

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 and 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

Education

• Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required.
• Advanced degree (PhD, PharmD, MS) strongly preferred.