Job Scope & Purpose:
Our client, an emerging biotech company developing compounds in rare disease and led by a team of veteran biotechnology executives, is seeking an experienced Regulatory Affairs professional to join this growing team. This Director/AD Regulatory strategist will partner with an experienced VP Regulatory professional to think outside the box and take an innovative, resourceful approach to deliver INDs and NDAs for the 2 compounds in development and 3rd forthcoming. The incumbent will provide regulatory leadership and oversight of the execution of the strategies, including management and maintenance of all regulatory applications within the US, EU, and ROW associated with the assigned programs.
Primary Job Responsibilities:
Manage regulatory communication with regulators (globally) as assigned, including submission correspondence, as well as assist with informal and formal Agency meetings, responses to Agency requests, and pre-meeting packages.
Ensure effective timeline management for the preparation and review of major applications, including ODAs, BTD, CTAs, INDs, NDAs, BLAs, MAAs, RPDs, and all equivalent submissions globally within the established timelines.
Maintain all regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and postmarketing submission deliverables.
Assist direct manager to advise cross-functional teams of regulatory strategies that optimize and expedite development and maximize the probability of success by mitigating anticipated risks.
Regulatory representative on assigned drug project teams, providing regulatory guidance and recommendations to the cross-functional teams that are in line with the company goals, global laws and regulations, and supporting the preparation and implementation of the product development plan.
Representative on commercial teams, including promotional review committees, medical affairs committees, labeling teams, and others as assigned.
Responsible for the development and implementation of investigational and commercial labeling, including leading labeling negotiations with the regulators, working with cross-functional teams to ensure labeling is consistent with all laws and regulations, and for investigational products develop and maintain a target product profile.
Manage coordination with Reg Ops Teams (medical writers, publishers) for all submissions to Agencies to ensure proper direction, preparation, and quality QC is performed, and that all submissions are timely and in compliance with all Agency laws.
Conduct frequent Regulatory Intelligence related to the assigned programs and disseminate relevant information to Sr. Management and cross-functional teams.
Prepare, present, and track budgets for any R&D and commercial activities needed for the assigned program.
Assist with all regulatory business development efforts as needed, which may include preparing and conducting presentations, due diligence activities, and application transfers.
When applicable, mentor and direct junior level regulatory personnel, who may or may not report directly to the incumbent.
Assist and/or manage other related activities as assigned.
Primary Job Requirements:
Advanced degree (MS, PhD, PharmD) from an accredited institution in a scientific discipline
Minimum of 8 years regulatory affairs experience
Experience with leading, preparing, and submitting successful submissions; preferable US and EU marketing application submission experience.
Fluent with Microsoft Office (word, excel, powerpoint) and pdf rendering software
Excellent written and oral communication skills
Ability to analyze and interpret scientific data and regulations
Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs
Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledgeable of global operational regulations and guidelines.
Experience in line-management and/or mentoring less experienced employees
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