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Sr. Manager, Regulatory Affairs

At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare.  We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease.  We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally.  This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

Job Summary:

The manager/senior manager of Regulatory Affairs will support the development of global regulatory strategies to advance Blueprint’s portfolio. Reporting to the Director of Regulatory Affairs, this individual will provide strategic input and operational regulatory support to cross-functional teams responsible for development and registration of Blueprint compounds. The individual will also ensure effective communication and constructive working relationships with external collaborators and regulatory authorities.


  • Responsible for day-to-day management of regulatory aspects of at least one clinical development program
  • Responsible for managing and completing relevant submissions for assigned program(s), including but not limited to: an IND, CTAs, annual reports, safety reports etc.
  • Represent the Regulatory Affairs function on cross functional teams
  • Support manager in developing and implementing long and short-term product regulatory strategies/plans
  • Support the manager in the preparations for health authority meetings
  • Provide guidance to external programs vendors and consultants
  • Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs


  • Bachelor’s degree; advanced scientific related degree a plus
  • A minimum of 3-5 years of regulatory drug development experience
  • Experience in rare disease or oncology drug development preferred; experience in pediatric development a plus
  • Must have experience filing INDs; CTAs and marketing application experience a plus
  • Solid working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, and ROW regulatory requirements a plus


  • Able to work well with others and communicate with senior leadership
  • Strong oral and written communication skills, and negotiation skills
  • Willing to drive and manage aggressive project timelines
  • Well organized, with an attention to details and capable of managing multiple deliverables
  • Capable of strategic thinking and proposing innovative solutions to regulatory problems
  • Must be proficient in Microsoft WORD, Project, PowerPoint, and Adobe Acrobat
  • At home in a results-driven, highly accountable environment where you can make a clear impact
  • A team player, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, national origin, disability or protected veteran status.


Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

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