Senior Director, Regulatory Affairs

The Position:

This highly dynamic team is seeking an entrepreneurial and strategic Sr. Director, Regulatory to play a key role on the cross-functional R&D team. This role will be responsible to lead and contribute to drug develop into innovative global regulatory strategies that expedite development, maximize the probability of success, identify regulatory opportunities, and mitigate risks. The individual in this position will have the unique opportunity to grow and mentor regulatory scientists on regulatory requirements and regulatory environmental trends, as well as help shape the regulatory approach in a rapid-growth biotech startup.

Key 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 the 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.
• Guide, lead, teach, mentor/coach, and supervise regulatory staff in the management of regulatory deliverables.
• Provide creative regulatory solutions to guide development and to present viable options for the team to consider, both opportunistic options and mitigations for risks.
• Manage global registrations with internal and/or external resources.
• 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 influence regulatory strategies that expedite development, maximize the probability of success, and mitigate risks, based on knowledge of the regulatory environment.
• Maintain a high degree of knowledge and awareness of the external environment and work with external associations & global regulatory bodies to remain current. Proactively adapt regulatory strategies and influence change within areas of responsibility.
• Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables. Interact efficiently and independently with consultants.

Requirements:

• 10-12 years of biopharmaceutical experience, which includes at least 8-10 years of direct experience in Regulatory Affairs
• An advanced degree (Master’s or Ph.D.) in a relevant scientific discipline is preferred.
• Experience in biologics drug development, and parenteral products, including combination products, and 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, Clinical Trial Applications, and Agency queries.
• Prior experience leading multiple 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.
• Ability to problem-solve development hurdles and apply learnings.
• Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, 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 the 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.
• Experience developing regulatory strategies for biologics and/or rare disease development programs.
• 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).