Manager, Regulatory Compliance and Operations

We seek a Manager, Regulatory Compliance and Operations who will work with other Regulatory birds and even cross-functionally with our other talented bluebirds to meet our compliance obligations as a regulated industry and continuously improve upon our processes and procedures to ensure that we can most efficiently support the business and our patients.
Full Time On-Site/Hybrid Regulatory Affairs
Annually: USD 120180 - 168350
Manager Regulatory Compliance
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Available Locations:
Somerville, Massachusetts, United States
ABOUT THE NEST

The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:

  • Persist for Purpose
  • Be Compassionate
  • Stay humble and curious
  • Keep it real
  • Celebrate (sm)all wins

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

ABOUT THE FLOCK

The Regulatory Science flock is all about making a profound impact on people living with rare diseases through teamwork, strategic conviction, operational focus, and individual accountability to the mission of establishing gene therapy as a meaningful option for patients. We seek a Manager, Regulatory Compliance and Operations who will work with other Regulatory birds and even cross-functionally with our other talented bluebirds to meet our compliance obligations as a regulated industry and continuously improve upon our processes and procedures to ensure that we can most efficiently support the business and our patients. Come work with a kickass group of birds that are committed to be the change that we want to see in the world….and have some fun together along the way!

HOW YOU’LL FLY

You’ll help to bring patients and their families more bluebird days by:

  • Inspection-readiness, preparation, and follow-up
  • Training compliance and metrics
  • Preparation and management of procedural documents
  • Responses to requests for regulatory documentation
  • Creating contracts and scope of work documents from templates and requesting purchase orders
  • Regulatory surveillance
  • Communications

WHAT YOU’LL BRING

You’re the bird we’re looking for if you have:

  • A Bachelor’s degree
  • Experience with the Microsoft suite of software, e.g., Word, Excel, SharePoint, Project, PowerPoint, Visio
  • Ability, interest, and willingness to learn new job-specific software systems, e.g., contracting systems, Oracle
  • Experience working or interacting in a hybrid or fully-remote work environment
  • Experience organizing information or managing large projects
  • Demonstrated attention to detail
  • Strong verbal and written skills

Compensation & Benefits

We offer a total compensation and rewards package that ranks among the best in our industry. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The anticipated annualized salary range for this role is $120,180-$168,350. Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements. Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as 28 paid holidays, including 2 company shutdowns.

Posted 11 months ago

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