Associate Director, Regulatory Strategy (Postmarketing)

Company: bluebird bio
Location: Somerville
Posted on: November 17, 2023

Job Description:

ABOUT THE FLOCK
The Regulatory 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 an experienced Associate Director, Regulatory Science who will be responsible for the regulatory strategy and lifecycle management for one of bluebird bio's orphan gene therapy programs. 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:

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• Supporting regulatory strategy for life cycle management of a rare disease gene therapy product.
  
• Collaborate with regulatory and cross-functional colleagues on the preparation and submission of high-quality regulatory dossiersaccording to set timelines; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science
  
• Participate in negotiations with regulatory agencies to resolve issues, preparing and submitting responses to questions, and managing interactions with regulatory agencies
  
• Collaborating with regulatory CMC, regulatory operations, and medical writing functions to ensure seamless integration of various components into submissions as well as high quality submissions per agreed to timelines.
  
• Reviewing technical documentation and regulatory documents for conformance with applicable regulations and alignment with regulatory guidance and internal style guidelines and requirements
  
• Maintaining knowledge of global competitive landscape, regulatory environment, regulations, and guidelines and participating in regulatory intelligence activities
  
  WHAT YOU'LL BRING
  You're the bird we're looking for if you have:
  
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  • BA/BS degree in life sciences, MS/PhD preferred and 8+ years of pharmaceutical product development, of which at least 6 years in regulatory strategy, preferably in biologics for rare diseases
    
  • Experience in IND/CTA, marketing applications (e.g., BLA submissions), and/or post-approval lifecycle dossier management
    
  • Well-versed in regulatory strategy, and regulatory science writing
    
  • Results-driven with an enthusiastic attitude, and the ability to influence outcomes
    
  • Exceptionally strong team leader and team player with excellent communication skills, coaching, project management, problem-solving, risk management, and presentation skills
    
  • Ability to work effectively in a collaborative team environment
    
  • Understanding of advanced therapy products development
    
  • Knowledgeable in ICH and FDA guidelines
    
    Compensation & BenefitsWe 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 $159,650 - $207,308. 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.
    
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Keywords: bluebird bio, Somerville , Associate Director, Regulatory Strategy (Postmarketing), Executive , Somerville, Massachusetts