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Associate Director/Director, Regulatory Affairs

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.

Job Summary:

The Associate Director/Director of Regulatory Affairs will be responsible 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.

Responsibilities:

Responsible for day-to-day management of regulatory aspects of multiple clinical development programs
Accountable for all relevant health authority 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

Qualifications:

Bachelor’s degree; advanced scientific related degree a plus
At least 8 years of pharmaceutical industry experience, with at least 6 years of regulatory experience
Experience in oncology drug development a plus
Must have filed INDs, CTAs, and/or NDA/BLAs to FDA and ex-US regulatory agencies
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

Capabilities:

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

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

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.

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