Array has 2 openings for either a Regulatory Affairs Manager or Regulatory Affairs Sr. Manager. These positions will report into Regulatory Affairs and Quality Assurance Department and will have interaction with preclinical, clinical and chemistry, manufacturing and controls departments. This is a “hands-on” position and will take on projects to support program teams.
Participate in the development and implementation of regulatory strategy for one or more programs and ensure successful regulatory filings
Working in a team environment, will plan and coordinate all aspects of regulatory submissions necessary to support clinical trials and product registration
Represent the department on multidisciplinary product development teams
Assess and communicate regulatory requirements for clinical and preclinical submissions and programs to assure that all development activities are in compliance with applicable US and pertinent international regulations and guidelines
Coordinate and supporting the writing of INDs, Canadian CTAs, IMPDs and ROW investigational applications
Assist in preparation of regulatory agency meeting minutes and assisting in the preparation of briefing documents
Ensure timely submission of appropriate regulatory documents individually, as a regulatory team, or through contract organizations
Maintain compliance with regulatory commitments
Works efficiently and effectively within regulatory teams, fostering collaborative exchanges, teamwork, and mentoring of colleagues
Will write regulatory SOPs and ensure SOPs are in compliance with current regulatory requirements
Work with Regulatory Operations to develop submissions in electronic and legacy format
Skills and Requirements
BA/BS degree in a scientific/health sciences discipline
5-7 years experience in pharmaceutical Regulatory Affairs (level will be determined by experience)
Experience in the management and preparation of regulatory agency submissions
Experience working with regulatory agencies
Oncology experience a plus
Ability to communicate effectively (written and verbal) and adapt to a changing environment
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.