Director/Senior Director, Regulatory Affairs Advertising and Promotion

Verastem Oncology
Boston, MA | Full-Time | Senior

Company Profile:

At Verastem Oncology we care differently and because of this we hire differently. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. Our team has the drive and capacity to embrace rapid growth, celebrate achievements and then quickly return focus to work, because our patients are counting on us. Our mission is to discover and develop drugs to improve outcomes for patients with cancer. This commitment is central to who we are as a company and the culture we nurture. We appreciate your candidacy for the Verastem Oncology team, and encourage you to learn more about how we care differently at www.verastem.com.

Provide regulatory expertise, guidance and thorough review of promotional and non-promotional materials as a member of the MLR (Medical, Legal, Regulatory) Committee for all externally facing materials and applicable internal communications, ensuring compliance with applicable laws, regulations, and guidance. In addition, participate as needed in other regulatory generalist activities (NDA, IND, etc.). This position will require the employee to have foresight, be action oriented, be a good communicator and work well within local and global project teams.

Responsibilities:

  • Attend promotional review meetings, review promotional materials and provide comments in accordance with SOPs, marketing timelines, and FDA regulations.
  • Collaborate directly with marketing teams from concept through review and approval, up to and including OPDP submissions
  • Contribute to process improvement initiatives related to advertising and promotion.
  • Contribute to developing RA best practices such as work instructions and SOPs for product promotional activities to establish standards and consistency across company brands
  • Maintain regulatory expertise in product promotion compliance by keeping current with issued FDA enforcement actions and by monitoring trends
  • Communicate new regulatory standards pertaining to prescription drug promotion and advertising to marketing teams and management
  • Assist in preparation and submission of INDs and IND amendments for domestic investigational products
  • Assist in preparation and submission of international Clinical Trial Applications
  • Participate in the development and implementation of short- and long-term Regulatory plans for key projects
  • Guide Nonclinical and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs
  • Perform nonclinical and clinical GAP analyses of dossiers being considered for registration of products in the U.S.
  • Guide and oversee the preparation of electronic datasets to be submitted to health authorities
  • Be creative and work within project teams to guide and advise the teams regarding the most efficient Regulatory product development and approval pathways
  • Strategize and guide preparation of responses to inquiries from domestic and international regulatory authorities
  • Monitor and update national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel
  • Assist other Department staff in the preparation and submission of applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal departments (Manufacturing, QA/QC, Medical, etc.) to update investigational and commercial dossiers and labeling
  • This position requires a team and goal oriented individual to interact with the various functional groups. Significant experience is required in the preparation of nonclinical and clinical sections of INDs and NDAs/BLAs

Qualifications:

  • Minimum of a bachelor’s degree in an applied science field, with significant experience in the review of advertising and promotional materials required
  • Preparing INDs and NDAs/BLAs
  • The candidate will have 6+ years of experience in the pharmaceutical industry required
  • Outstanding working understanding of the U.S. regulatory environment