Blueprint Medicines is a top-tier, publicly-traded (BPMC) Biopharmaceutical Company focused on discovering, developing and commercializing highly-selective kinase inhibitors for genomically defined diseases. Originally funded by Third Rock Ventures, the company has built a sophisticated genomics platform and a one-of-kind annotated compound collection which is delivering a pipeline of novel therapies. In just three years, four programs have been established in genomically defined cancers and one program in the rare genetic disease space.
The Director of Regulatory Affairs will have primary responsibility for developing global regulatory strategies to advance Blueprint’s oncology portfolio. Reporting to the Head 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 in orphan oncology indications. 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 multiple clinical development programs
- Oversees and accountable for all relevant submissions and approvals for assigned program(s)
- Represent the Regulatory Affairs function on core development teams
- Develop and monitor long- and short-term product regulatory strategies/plans and oversee implementation of the project plan. Make decisions on issues that could delay project schedules or activities; provide input on budget requirements; monitor project performance against goals
- Plan for and lead preparation efforts for health authority meetings
- Provide oversight and 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 10 years of pharmaceutical industry experience, with at least 8 years of regulatory experience
- Experience in oncology drug and companion diagnostic development strongly preferred
- Must have filed INDs, CTAs, and/or NDA/BLAs to FDA and ex-US regulatory agencies
- Experience in managing multiple global programs/filings required
- Solid working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus
- Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy
- Able to work well with others and communicate with senior leadership
- Strong oral and written communication skills, and negotiation skills
- Willing to set and drive aggressive project timelines
- 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
WHO WE ARE:
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.