Manager/Sr. Manager, Regulatory Affairs CMC
Manager/Sr. Manager, Regulatory Affairs CMC
Location: Cambridge, MA
Requisition Number: 166
Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy.
What will you do?
The incumbent in Regulatory Affairs CMC will be responsible for developing global regulatory strategies to advance Blueprint’s portfolio. This position will lead and contribute to activities in support of high-quality CMC sections of regulatory documentation.
What will be your responsibilities?
- Work with internal partners to develop regulatory CMC strategies, identify potential regulatory risks, and develop contingency plans for projects in various phases of development.
- Manage and lead assigned projects, including timelines and submission planning.
- Plan and prepare CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities
- Ensure the timely completion of regulatory filings such as CTA, IMPD, IND and associated amendments.
- Evaluate CMC change controls and provide regulatory input pertaining to all facets of manufacturing changes.
- Exercise good judgment in elevating and communicating actual or potential issues.
- Provide feedback and guidance in accordance with phase-appropriate regulatory expectations to ensure the quality and safety of clinical product.
What basic qualifications do we require?
- Bachelor’s degree in a scientific/engineering field (advanced degree preferred).
- At least 5 years of pharmaceutical industry experience and solid understanding of drug development process.
- Must have experience in pharmaceutical development (e.g. analytical, process, formulations, quality).
- At least 3 years of regulatory CMC experience with US product development including CMC life cycle management.
What additional qualifications are we seeking?
- Experience with Global post-approval regulations/guidance, strategies and submissions.
- Proficient in Microsoft WORD, Project, PowerPoint, and Adobe Acrobat.
- Ability to set and drive aggressive project timelines
- Ability to resolve complex and ambiguous situations, with ability to understand the scientific principles as it relates to regulatory requirements and strategy.
- Capable of critical thinking and proposing innovative solutions to regulatory problems
- At home in a results-driven, highly accountable environment where you can make a clear impact
- A standout colleague, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
COVID-19 Vaccination Requirement
As a biotechnology organization, it is our responsibility to do everything we can to safeguard the health and safety of our workforce, our communities, and the patients we serve. That is why we require all employees to be fully vaccinated against COVID-19, unless we approve an exemption through a reasonable accommodation for certified health reasons or sincerely held religious beliefs. Accommodation requests for either of these reasons should be made to TotalRewards@blueprintmedicines.com.
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 who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, please reach out to TotalRewards@blueprintmedicines.com.
For more information, please see our EEO-AA-Policy-Statement, the EEO Poster and its Supplement, as well as our Pay Transparency Statement.
Who we are:
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 matters and that our success depends on our ability to work together in a diverse community. We believe we are at our best as a company when our employees are thriving and we foster a culture that provides opportunities to grow and develop professionally, while also having fun.