Associate Director, Regulatory Affairs

Nuvation Bio•Remote - Any State US, NY

1d•Hybrid

About The Position

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. As a key member of the Nuvation Regulatory Affairs team, you will collaborate with a cross-functional team and global licensing partners to further develop commercial stage assets. We are looking for an experienced hands-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions for Nuvation products.

Requirements

Bachelor or Master’s degree required
Minimum of 10 years equivalent experience in drug development/regulatory affairs in the biopharmaceutical industry
Experience with drug development and commercial product regulatory requirements
Familiar with eCTD, e-publishing systems, and direct experience in preparing regulatory submissions is required; strong authoring and content editing skills required
Deep knowledge of FDA regulations is required
Self-starter and influential team player
Ability to 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
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.

Nice To Haves

NDA experience is preferred
experience with marketing applications outside of the US (e.g. MAA, NDS) desirable
Experience with supporting global clinical studies is desired
Located in Boston area preferred

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