Associate Director, Regulatory Affairs - Contract

Job Description

Job 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 to advance clinical stage programs and 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...

Communication & Interpersonal Skills :

Behavioral skills to be successful...

What we have for you!

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.