Associate Director/Director - Regulatory Affairs

Role: 

Be Biopharma is looking to hire highly motivated, experienced, and innovative thinkers to join our growing team of passionate researchers to leverage B cells as a novel class of cellular medicine. This is an exciting opportunity to be part of a foundational team and help build Be Bio! 

This highly dynamic team is seeking an entrepreneurial and strategic (Associate) Director, Regulatory Affairs to play a key role on our cross-functional R&D team. In this role, you will have the opportunity to lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. The individual in this position will have the unique opportunity to shape the Regulatory function of a rapid-growth biotech startup.

Responsibilities:

• Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global regulatory requirements and strategy are understood by project teams
• Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries
• Close collaboration with internal and external cross-functional team members to ensure achievement of submissions and timely approvals of applications
• Lead interactions with FDA and other Health Authorities
• Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments, deliverables, and overall project timelines
• Maintain up-to-date knowledge and understanding of global regulatory requirements.
• Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives
• Provide hands-on leadership to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries
• Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables. Interact efficiently and independently with consultants
• Provide hands-on leadership to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries
• Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables. Interact efficiently and independently with consultants

Experience, Education, Specialized Knowledge, and Skills:

Must thrive in a fast-paced, growing, and innovative environment where flexibility, resourcefulness, resiliency, and communication skills are key. Excellent interpersonal skills, ability to develop important relationships with your stakeholders, and being an all around good company citizen are essential.

• 7-9 years of biopharmaceutical experience, which includes at least 5-6 years of direct experience in Regulatory Affairs  
• Advanced degree (Master’s or PhD) in a relevant scientific discipline is preferred
• Experience in cell and gene therapy or biologics drug development, orphan/rare disease product development 
• Experience in developing and implementing regulatory strategies in a global environment. 
• Comprehensive understanding of applicable global regulations, guidance, and practices
• Demonstrated hands-on experience in the preparation and submission of global regulatory documents including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, and agency queries
• Prior experience leading interactions with FDA and other global regulatory authorities
• Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations 
• Strong team and project management skills
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership
• Ability to thrive in a collaborative and fast-paced environment
• Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight
• Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidances
• Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents
• Commitment to company values and culture
• Proven ability to adapt to change and uncertainty as projects evolve
• Strong oral and written communicator
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks
• Ability to multi-task and adjust priorities quickly while working under tight deadlines.
• Skilled in developing collaborative internal and external relationships
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project)

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