Associate Director, Regulatory Affairs

Nuvation Bio; United States; On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Competitive Base Salary

Unlimited Vacation

401K with Company Matching

Excellent Medical, Dental, and Vision Coverage

Job summary

Nuvation Bio is seeking an experienced Regulatory Affairs professional to join its team in the Boston area. This position involves working with cross-functional teams to develop strategies for regulatory submissions, ensuring compliance with requirements for drug products.

Your role will include the management of submissions to U.S. and international regulatory authorities along with direct interaction with these agencies. A Bachelor's or Master's degree and at least 10 years of experience in the biopharmaceutical industry are required.

Qualifications

• A minimum of 10 years in drug development/regulatory affairs.
• Experience with drug regulatory requirements and submissions.
• Ability to travel domestically and internationally up to 10%.

Responsibilities

• Develop and contribute to regulatory strategies for drug development.
• Prepare documents for U.S. regulatory authorities.
• Manage interactions with regulatory agencies.

Skills

Regulatory strategies development

Communication skills

Problem-solving

FDA regulations knowledge

Collaborative teamwork

Education

Bachelor or Master’s degree in relevant field

Tools

eCTD

e-publishing systems

Job description

Overview

Who We Are… 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.

What You’ll Be Doing

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.

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

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

Behavioral Skills

• 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.

Benefits

• Competitive Base Salary, Bonus, and Equity Plans
• Unlimited Vacation and 10 Sick Days Annually
• Excellent Medical, Dental, and Vision Coverage
• 401K with Company Matching
• and much more!

Base pay will take into account internal equity and may vary depending on the candidate’s job‑related knowledge, skills, experience, and location among other factors. Our full‑time regular positions also include an annual performance‑based bonus and long‑term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.

Disclaimer

Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.