Description
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.
You will be responsible for…
- 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
What Knowledge & Experience you'll bring to us...
- 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 to be successful...
- 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.
What we have for you!
- 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!
The base pay offered will take into account internal equity and also 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.
Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
