Will provide input for the strategic regulatory direction and operational regulatory expertise to advance Array’s drug candidates. The ideal candidate will have a direct role in implementing regulatory policy throughout the drug development process and manage 1-2 employees. They will provide a hands-on approach with the ability to assist in the growth of the regulatory group. The candidate must be a credible, influential spokesperson for interactions and negotiations with regulatory authorities and agencies.
Contribute to the development of regulatory strategy plans (clinical, non-clinical, CMC, labeling)
Interprets FDA, ICH, and other applicable guidelines and regulations, anticipates regulatory concerns, addresses proposed legislations and regulations, and integrates regulatory requirements into development programs at an early stage to assure compliance
Drives documentation to regulatory agencies (IND/CTA, NDA/MAA) setting the standards for regulatory submissions to assure adequacy, completeness and regulatory accuracy
Provides regulatory input into study protocols, statistical analysis plans, clinical study reports and other documents that support development and registration
Coordinate preparation of information and related activities for meetings with health authorities
Ensure the quality and content of submissions to health authorities
Crafts high risk/impact regulatory rationale included in clinical trial applications amendments, and market applications
Monitors changes to development plans and provide regulatory guidance to teams
Establishes and communicates regulatory policy to internal customers and provides clarity of regulatory expectations
Acts as a direct contact point with health authorities for clinical, non-clinical and CMC issues
Maintains effective relationships with other functional areas (Clinical Operations, Data Management, Clinical QA, Statistics, Drug Safety, etc.)
Manages, mentors, trains and develops regulatory staff
Provides input in the selection of clinical and regulatory vendors (i.e. due diligence activities)
Liaise with partnering companies to ensure regulatory alliance
Skills and Requirements
BS (prefer advanced degree, PhD in Life Science or PharmD) plus training in regulatory affairs
10+ years pharmaceutical or biotech industry experience in drug development, including 7+ years of regulatory affairs experience
Experience in oncology development is desirable
Experience managing, mentoring, growing and leading a team of regulatory professionals
Experienced in preparing / reviewing regulatory IND/CTA and CTD NDA paper and/or electronic submissions
Collaborative team player that can establish and maintain effective working relationships with other departments, regulatory agencies, and outside vendors
Excellent interpersonal skills with knowledge of negotiations, influencing and conflict management to assure effective interactions within and across departments
Proficiency with Word and PowerPoint is required. Experience with Excel and MS Project is desired.
Ability to contribute extensive regulatory expertise and advice
Experience interacting with the FDA, Health Canada and European regulatory agencies desired
Excellent writing skills required
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer and inflammatory diseases. We offer an excellent compensation package including a competitive salary, company ownership and comprehensive benefits.
Array is an equal opportunity employer and drug free workplace.