The Role:

Reporting to the Senior Vice President, Global Regulatory Affairs, this position is responsible for …

Key Responsibilities: 

• Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global CMC regulatory requirements and strategy are understood by project teams.
• Play a hands-on role in planning, preparing, and coordinating CMC 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.
• Partner and work very closely with internal and external cross-functional team members to ensure achievement of submission deadlines and timely approvals of CMC-related applications
• Lead and support interactions with FDA and other Health Authorities for CMC-related topics.
• Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables.
• 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 the regulatory and manufacturing team in planning, preparing, and coordinating CMC documents submitted 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.

• Ability to communicate with CMC management and leadership on CMC creative filing strategies, summarize regulatory strategy and associated risks in a collaborative manner.

• Strong stakeholder partnership with Quality, project management, supply chain and CMC to enable open and robust discussions to achieve the best scientific decisions.
• Communicate project updates and risks to senior management and stakeholders throughout the organization. Track regulatory commitments and deliverables.  Interact effectively and independently with consultants.
• Ability to establish an integrated CMC regulatory strategy that anticipates risk, aligns with enterprise objectives, and secures cross-functional alignment across Technical Operations, Quality, and Program leadership.
• Leadership across CMC strategy and supervision. Expected to manage the CMC team and contractors supporting work, along with coaching and mentoring of the staff.

Requirements:

• Masters or PhD degree in a relevant scientific discipline, Advanced degree preferred
• 12+ years of biopharmaceutical experience, which includes at least 6 years of direct experience in Regulatory Affairs CMC
• Demonstrated, hands-on experience in biologics drug development, registration, and post-approval life cycle management in a global environment. Direct involvement with parenteral products, including drug-device combination development.
• Comprehensive understanding of CMC product development with biologics and drug-device combinations and knowledge of applicable global regulations, guidance, and practices
• Experience in the preparation and submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, and agency queries. Recent and relevant BLA filing experiences.
• Prior experience leading interactions with global regulatory authorities on CMC-related issues
• Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
• 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

Specialized knowledge, Licenses, etc.:

• Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight; track record of successful IND, CTA, NDA/BLA, and MAA submissions
• Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidance
• Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents
• Strong experience leading regulatory CMC strategy and input for biologics and drug-device combination development programs

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (10-20%)