Director, Regulatory Affairs Strategy

The job overview for this position is that bluebird bio is seeking an experienced Director, Regulatory Strategy to provide regulatory strategy and post-approval lifecycle management for one of their orphan gene therapy programs. The role involves collaborating with cross-functional teams, managing regulatory dossiers, interacting with regulatory agencies, and ensuring adherence to regulatory guidelines. The ideal candidate should have a background in pharmaceutical product development, regulatory strategy, and strong leadership and communication skills.

• Provide regulatory strategy for post-approval life cycle management of a rare disease gene therapy product, as well as development program with ongoing clinical studies
• Manage preparation and submission of high-quality regulatory dossiers in the US (and the EU) according 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
• Manage transparent and proactive regulatory agencies interactions
• Collaborate with regulatory-CMC function as needed
• Collaborate with pharmacovigilance to ensure timely submission of SUSARs, and quarterly PAERs
• Work cross functionally to ensure timely execution of submission activities related to fulfilling post marketing commitments, and responses to FDA information requests
• Participate in the cross-functional review and authoring sections as applicable, for the key clinical documents including investigator’s brochures, DSUR, protocols, clinical study reports
• Manage Ex-US regulatory activities related to continued conduct of clinical trials
• Drive adherence to regulatory guidelines/regulations for study conduct and post-approval lifecycle management of gene therapy products
• Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidelines and participate in regulatory intelligence activities

• BA/BS degree in life sciences, MS/PhD preferred
• 10+ years of pharmaceutical product development experience
• At least 8 years of experience in regulatory strategy, preferably in biologics for rare diseases
• Experience as primary regulatory lead for post-approval and IND/CTA submissions
• 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
• Excellent communication skills
• Coaching and project management skills

• Total compensation and rewards package that ranks among the best in the industry
• Base pay determined within a range, providing opportunity for progression
• Anticipated annualized salary range of $187,000 - $252,179
• Eligibility for stock, incentive bonuses, and benefit programs
• Flexible time off program
• 28 paid holidays, including 2 company shutdowns
• Commitment to fostering diversity and inclusion
• Equal opportunity employer, creating a welcoming and diverse environment