Key Responsibilities:Manages the day-to-day regulatory activities of assigned projects for compounds under development and/or marketed. These activities include acting as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities.Actively participates on Project Teams in the development, creation, and implementation of regulatory and development products by providing regulatory guidance and compliance oversight for regulated products.Works collaboratively with Project Teams in the development of draft labeling for drug development candidates. Participates on cross-functional teams to establish regulatory strategy for developing content for draft package inserts for NDA submissions.Interfaces with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies. Demonstrates leadership in developing partnerships both internal and external to the company. Accurately assesses and conveys regulatory risk/opportunities and influences decision makers.Responsible for managing the compilation, submission and maintenance of INDs, NDAs, MAAs, CTAs, amendments, and supplements.Supports and participates in the Company's due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.Facilitates the regulatory strategy and serves as a Company contact with FDA and ex-US regulatory agencies.Liaises with the FDA review divisions and represents Regulatory at FDA meetings (e.g. pre-IND, EOP2, Pre-NDA) and with global health authorities and development partners as appropriate for their projects.Leads the preparation for meetings conducted with CDER, including rehearsals and development of meeting requests and briefing books.Monitors the regulatory environment and communicates developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc).Applies strong technical regulatory knowledge to advising business functions regarding regulatory requirements to enable successful implementation of business strategies.Provides expert leadership, advice, and direction regarding scientific and medical issues as related to application of the FDA and other regulatory requirements for regulated products.Deploys Liaison staff to effectively, efficiently, and collaboratively support business requirements ensuring regulatory compliance for development and marketed products.Qualifications:BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.Minimum 10 years branded regulatory pharmaceutical drug development experience. Broad based therapeutic area and product experience.Strategic regulatory affairs experience with a proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.Demonstrated experience supporting and conducting due diligence activities.Demonstrated experience interacting with global health authorities.Strong knowledge of regulations/guidelines governing global development of pharmaceuticals is required.Excellent communication skills and proven negotiation skills. Must be able to effectively communicate with scientists at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies.Compensation:Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
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