Director, Global Regulatory Affairs (GRA) - CMC
Ironwood Pharmaceuticals
6 hours ago
Remote friendly (Boston, MA)
United States
$208,000 - $243,600 USD yearly
Corporate Functions
Director, Global Regulatory Affairs – CMC
Purpose / Summary
- Own and lead global CMC regulatory strategy and execution to enable clinical development, commercialization, and lifecycle management.
- Serve as the single-point CMC regulatory lead for assigned programs, accountable for regulatory strategy, health authority engagement, submission quality, and inspection readiness.
Essential Functions
- Lead and own global CMC regulatory strategy across development, registration, and lifecycle management; identify key risks, remediation activities, and acceleration opportunities while ensuring approvability and inspection readiness.
- Serve as regulatory CMC representative on internal CMC teams, core submission teams, and cross-functional governance forums.
- Provide strategic global Regulatory Affairs–CMC guidance to project teams; ensure timely execution of integrated regulatory project plans.
- Assess, interpret, and communicate global CMC regulatory requirements to ensure compliance with applicable regulations, guidelines, and regional expectations.
- Initiate, lead, and manage interactions with global health authorities (FDA, EMA, PMDA, and others) to align on strategy, negotiate data requirements, resolve issues, and support timely approvals.
- Lead preparation of CMC briefing packages and regulatory narratives for health authority meetings; define regulatory positions, risk mitigation strategies, and supporting data; participate in/lead agency interactions as a spokesperson.
- Provide regulatory leadership for GMP inspections and PAI readiness (inspection preparation, response strategy, and alignment with Quality/Tech Ops commitments).
- Coordinate, review, and ensure quality/timeliness of global CMC submissions and lifecycle filings (original INDs; CMC/IMPD amendments; annual reports; meeting requests; briefing packages; marketing applications; post-approval changes).
- Manage external contractors/collaborators to ensure accurate, compliant regulatory deliverables and successful execution.
- Establish and lead CMC regulatory governance (review cadence, risk escalation pathways, and communication of status/risks/decisions to leadership).
- Stay current on evolving global regulations, standards, policies, and guidance; assess impact to development and commercial programs.
- Partner with cross-functional stakeholders to proactively identify, escalate, and resolve CMC regulatory issues impacting timelines or approval readiness.
Requirements
- Bachelor’s degree in a scientific discipline (Biology, Chemistry, or Pharmaceutical Sciences); advanced degree preferred.
- Minimum 10 years in CMC Regulatory Affairs within the biopharmaceutical industry with progressively increasing responsibility.
- 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).
- Ability to develop and defend CMC regulatory strategies supporting new product development, commercialization, and lifecycle management.
- Strong track record of global regulatory interactions/submissions for biologics, innovative medicines, and/or combination products (US, EU, and other regions).
- Ability to provide risk-based regulatory decision-making and strategic recommendations to senior leadership.
- Strong leadership, communication, and interpersonal skills; ability to diplomatically influence cross-functional decision-making.
- Ability to work independently in matrixed, cross-functional teams and with external partners.
- Excellent written/verbal communication, organizational, and project management skills.
- Ability to operate in a fast-paced environment while managing multiple priorities.
Benefits
- Restricted Stock Unit awards; eligibility for a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; medical, dental, vision, and prescription drug benefits; wellness stipends; generous vacation/holiday schedule.
Purpose / Summary
- Own and lead global CMC regulatory strategy and execution to enable clinical development, commercialization, and lifecycle management.
- Serve as the single-point CMC regulatory lead for assigned programs, accountable for regulatory strategy, health authority engagement, submission quality, and inspection readiness.
Essential Functions
- Lead and own global CMC regulatory strategy across development, registration, and lifecycle management; identify key risks, remediation activities, and acceleration opportunities while ensuring approvability and inspection readiness.
- Serve as regulatory CMC representative on internal CMC teams, core submission teams, and cross-functional governance forums.
- Provide strategic global Regulatory Affairs–CMC guidance to project teams; ensure timely execution of integrated regulatory project plans.
- Assess, interpret, and communicate global CMC regulatory requirements to ensure compliance with applicable regulations, guidelines, and regional expectations.
- Initiate, lead, and manage interactions with global health authorities (FDA, EMA, PMDA, and others) to align on strategy, negotiate data requirements, resolve issues, and support timely approvals.
- Lead preparation of CMC briefing packages and regulatory narratives for health authority meetings; define regulatory positions, risk mitigation strategies, and supporting data; participate in/lead agency interactions as a spokesperson.
- Provide regulatory leadership for GMP inspections and PAI readiness (inspection preparation, response strategy, and alignment with Quality/Tech Ops commitments).
- Coordinate, review, and ensure quality/timeliness of global CMC submissions and lifecycle filings (original INDs; CMC/IMPD amendments; annual reports; meeting requests; briefing packages; marketing applications; post-approval changes).
- Manage external contractors/collaborators to ensure accurate, compliant regulatory deliverables and successful execution.
- Establish and lead CMC regulatory governance (review cadence, risk escalation pathways, and communication of status/risks/decisions to leadership).
- Stay current on evolving global regulations, standards, policies, and guidance; assess impact to development and commercial programs.
- Partner with cross-functional stakeholders to proactively identify, escalate, and resolve CMC regulatory issues impacting timelines or approval readiness.
Requirements
- Bachelor’s degree in a scientific discipline (Biology, Chemistry, or Pharmaceutical Sciences); advanced degree preferred.
- Minimum 10 years in CMC Regulatory Affairs within the biopharmaceutical industry with progressively increasing responsibility.
- 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).
- Ability to develop and defend CMC regulatory strategies supporting new product development, commercialization, and lifecycle management.
- Strong track record of global regulatory interactions/submissions for biologics, innovative medicines, and/or combination products (US, EU, and other regions).
- Ability to provide risk-based regulatory decision-making and strategic recommendations to senior leadership.
- Strong leadership, communication, and interpersonal skills; ability to diplomatically influence cross-functional decision-making.
- Ability to work independently in matrixed, cross-functional teams and with external partners.
- Excellent written/verbal communication, organizational, and project management skills.
- Ability to operate in a fast-paced environment while managing multiple priorities.
Benefits
- Restricted Stock Unit awards; eligibility for a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; medical, dental, vision, and prescription drug benefits; wellness stipends; generous vacation/holiday schedule.