Associate Director, Regulatory Affairs

Role Summary

Associate Director, Regulatory Affairs will lead regulatory strategy and submissions for Nuvation products, collaborating with cross-functional teams to advance clinical stage programs and develop commercial assets. The role involves planning, preparing, submitting, and maintaining regulatory documents for U.S. and international authorities, interacting with regulatory agencies, and contributing to pharmacovigilance as needed.

Responsibilities

• Regulatory representative for drug development project teams with responsibility for developing or contributing to regulatory strategies and requirements
• Responsible for the management, planning, coordination, and preparation of documents that are submitted to U.S. and, if required international, regulatory authorities, in support of INDs, NDAs, DMFs, CTAs, amendments, safety reports, and annual updates
• Responsible for interactions and direct contact with regulatory agencies
• Contributes to pharmacovigilance activities as needed
• Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations

Qualifications

• Required: Bachelor or Master’s degree
• Required: Minimum of 10 years equivalent experience in drug development/regulatory affairs in the biopharmaceutical industry
• Required: Experience with drug development and commercial product regulatory requirements
• Required: Familiar with eCTD, e-publishing systems, and direct experience in preparing regulatory submissions; strong authoring and content editing skills
• Preferred: NDA experience is preferred and experience with marketing applications outside of the US (e.g. MAA, NDS) desirable
• Required: Deep knowledge of FDA regulations
• Preferred: Experience with supporting global clinical studies is desired
• Self-starter and influential team player
• Required: Travel (domestic and international) up to 10%
• A demonstrated ability to collaborate, as well as to work independently, across a diverse range of areas, balancing competing priorities in a fast-paced environment with a high level of professionalism
• Located in Boston area preferred

Skills

• Excellent communication and interpersonal skills
• Stellar leadership skills for internal and external activities
• Must be able to write clearly and summarize information effectively
• Must be able to present complex information to various audiences
• High level organization skills as primary manager of internal docket coupled with exquisite attention to detail
• Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource
• Emotional intelligence, curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks