Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.        

Job Title: Manager, Global Regulatory Sciences

Location: Cambridge, MA   

Job Description:

As a Manager in Global Regulatory Sciences team, this role will have responsibility supporting and implementing the development of global regulatory strategies to advance and maintain Blueprint’s mast cell disease portfolio. 

Reporting to the Director of Global Regulatory Sciences, this individual will primarily provide regulatory support of both an operational and strategic nature to the Global Regulatory Lead(s) and cross-functional teams responsible for the development, registration and maintenance of Blueprint compounds in mast cell disease indications. The individual will also ensure effective communication and constructive working relationships with external collaborators and regulatory authorities.  

Responsibilities:

• Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program
• Responsible for relevant submissions for assigned program(s).
• Represent the Global Regulatory Sciences function on cross functional teams
• Support line manager in developing and implementing long and short-term product regulatory strategies/plans
• Plan for and lead preparation efforts for health authority meetings
• Provide guidance to external vendors and consultants as needed
• 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 in scientific discipline; advanced scientific related degree a plus
• 4 years or more in drug development; direct Regulatory experience is a plus 
• Experience in oncology/rare diseases drug development a plus
• Ideally experienced in filing and managing INDs to FDA
• Working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus 

Capabilities:

• Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships
• Well organized, with an attention to details and capable of managing multiple deliverables
• A collaborator who communicates in an open, clear, complete, timely and consistent manner
• 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
• Flexible and adaptable in ambiguous situations
• Must be proficient in Microsoft WORD, Excel, PowerPoint as well as SmartSheet and Adobe Acrobat    

Pay Transparency:

The pay range that Magnit reasonably expects to pay for this position: $70.00 - 75.00 /hour.

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met).

Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

This is the place where the extraordinary becomes reality, and you could be part of it.

Patients are waiting. Are you ready to make the leap?

Equity, Diversity, Inclusion and Affirmative Action

At Blueprint Medicines, we foster a culture of equity, diversity, and inclusion.  A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We are also an E-Verify Employer.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement. 

Job Location: Cambridge, Massachusetts 

Contract Duration: 6 months

• Work Authorization : Authorized to work in the United States
• Preferred years of experience : 4+ yrs
• Travel Required : No travel required
• Shift timings: Not specified