Director, Global Regulatory Affairs (GRA) - CMC

Role Summary

Reporting to the Head of Regulatory Affairs CMC, the Director, Global Regulatory Affairs – CMC is responsible for owning and leading the global CMC regulatory strategy and execution to enable clinical development, commercialization, and lifecycle management of the company’s products. This role ensures that global CMC regulatory requirements are proactively identified, strategically addressed, and integrated into development and commercial plans. The Director serves as the single-point CMC regulatory lead for assigned programs, accountable for regulatory strategy, health authority engagement, submission quality, and inspection readiness.

Responsibilities

• Lead and own the global CMC regulatory strategy for assigned programs across development, registration, and lifecycle management, identifying key risks, remediation activities, and opportunities for acceleration while ensuring approvability and inspection readiness.
• Serve as the regulatory CMC representative on internal CMC teams, core submission teams, and cross-functional governance forums, providing authoritative regulatory input and decision-making support.
• Provide strategic global Regulatory Affairs–CMC guidance to project teams and ensure timely development and execution of integrated regulatory project plans.
• Assess, interpret, and communicate global CMC regulatory requirements to ensure all development and commercial activities comply with applicable regulations, guidelines, and regional expectations.
• Initiate, lead, and strategically manage interactions with global health authorities (FDA, EMA, PMDA, and other national competent authorities) to obtain alignment on CMC strategy, negotiate data requirements, resolve issues, and support timely approvals.
• Lead preparation of high-quality CMC briefing packages and regulatory narratives for health authority meetings, including definition of regulatory positions, risk mitigation strategies, and alignment of supporting data; participate in or lead agency interactions as a key spokesperson.
• Provide strategic regulatory leadership for GMP inspections and PAI readiness, including inspection preparation, response strategy, and alignment of regulatory commitments with Quality and Tech Ops execution.
• Coordinate, review, and be accountable for the quality and timeliness of global CMC regulatory submissions and lifecycle filings, including original INDs, CMC amendments, IMPD amendments, annual reports, meeting requests, briefing packages, marketing applications, and post-approval changes.
• Work directly with external contractors and collaborators, managing regulatory deliverables, communication pathways, and project plans to ensure accuracy, compliance, and executional success.
• Establish and lead CMC regulatory governance for assigned programs, including defining review cadence, risk escalation pathways, and communication of status, risks, and decisions to senior leadership and executive management.
• Remain current on evolving global regulations, standards, policies, and guidance issued by relevant regulatory authorities and assess impact to development and commercial programs.
• Partner with cross-functional stakeholders to proactively identify, escalate, and resolve CMC regulatory issues impacting development timelines or approval readiness.

Qualifications

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, or Pharmaceutical Sciences; advanced degree preferred.
• Minimum of 10 years of progressively increasing responsibility in CMC Regulatory Affairs within the biopharmaceutical industry.
• Demonstrated experience leading successful global marketing application submissions and approvals.
• Proven experience preparing CMC sections of global clinical trial applications (IND, IMPD, CTA).
• Experience with drug-device combination products preferred.
• Demonstrated ability to develop and defend CMC regulatory strategies supporting new product development, commercialization, and lifecycle management.
• Strong track record of successful global regulatory interactions and submissions for biologics, innovative medicines, and/or combination products in the US, EU, and other regions.
• Demonstrated ability to provide risk-based regulatory decision-making and strategic recommendations to senior leadership.
• Strong leadership, communication, and interpersonal skills with the ability to influence decision-making diplomatically across functions.
• Ability to work independently and effectively within matrixed, cross-functional teams and with external partners.
• Excellent written and verbal communication, organizational, and project management skills.
• Ability to operate in a fast-paced environment while managing multiple priorities.

Skills

• Leadership, communication, and interpersonal skills with the ability to influence decision-making diplomatically across functions.
• Strong written and verbal communication, organizational, and project management capabilities.
• Ability to work independently and effectively within matrixed, cross-functional teams and with external partners.
• Risk-based regulatory decision-making and ability to provide strategic recommendations to senior leadership.

Education

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, or Pharmaceutical Sciences; advanced degree preferred.