Director, Global Regulatory Affairs (GRA) CMC

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide) the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide a next-generation long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases including short bowel syndrome with intestinal failure as well as several earlier stage assets. Building upon our history of GI innovation we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

Purpose / 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 companys products. This individual ensures that global CMC regulatory requirements are proactively identified strategically addressed and fully 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. This role requires close collaboration with senior leadership and cross-functional stakeholders to define regulatory objectives manage risk and support timely high-quality global submissions and approvals.

Essential Functions:

• 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 AffairsCMC 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.

Requirements:

• Bachelors 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.

Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status.

Ironwood currently anticipates that the initial base salary for this position could range from between $208000K - $243600K. The actual base salary will depend in part on the successful candidates qualifications for the role including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical dental vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

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