Manager, Regulatory Operations, Publishing

Location
Cambridge, MA, United States
Posted
Dec 06, 2018
Ref
990305
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches. bluebird bio seeks an outstanding Regulatory Operations leader to drive a number of late, as well as, early stage marketing application projects.

We are looking for an innovative Manager, Submissions Publishing, whose primary responsibilities will be to manage all publishing activities for the assigned product(s), taking into account inter-dependencies of application content with other functions' related activities, and in parallel build submission content management processes to support the global development of bluebird's regulatory applications. This role will require strong communication and collaborative skills and a will to understand the complexity related to the development of early stage and late stage gene therapy programs.

About the role:
  • Develop and implement regulatory submission project and resourcing plans, establish goals, and measure progress toward critical milestones for major regulatory submissions
  • Manage vendors to support Regulatory submissions goals
  • Maintain submissions and associated activities' schedules
  • Advise colleagues on submission planning, providing technical background and identifying issues which may impact goals and timelines
  • Lead publishing efforts to coordinate timely, compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatory submission plan.
  • Partner with regulatory team members, as well as, members of the Project Management, Commercial, Clinical, Medical Affairs, Clinical Operations, Nonclinical, CMC and Quality functions within bluebird to ensure strong, clear communication and to identify and address challenging issues in the management of content for regulatory submissions. The primary focus will be on major marketing and clinical applications in order to achieve regulatory goals.
  • Foster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvement

About you:
  • A Bachelor's degree or Master's degree ideally in the life sciences
  • 5+ years of regulatory operations experience, preferably with major marketing application experience
  • 2+ years of regulatory submission management experience in a fast-paced, innovative drug development environment
  • Proven ability to successfully plan for and manage simultaneous major marketing applications while overseeing the routine daily maintenance of existing regulatory applications.
  • Successfully manage regulatory submissions projects such that they integrate effectively with the overall objectives of the development programs they support
  • Expertise using eCTD Publishing software such as Adobe and ARIM, as well as MS Office software suite, especially Word
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • A passion for addressing the critical unmet medical needs of patients
  • Excellent communications skills and ability to influence across multiple functions
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself