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, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities that support the company’s product development strategies and providing guidance to broader CMC functions. This individual will ensure all applicable CMC regulatory requirements are considered and appropriately incorporated into clinical and commercial product development plans. This individual will work collaboratively with senior leadership and key stakeholders to develop CMC regulatory objectives for one or more programs, lead the preparation and filing of regulatory CMC submissions, and manage the preparation for interactions with Health Authorities. The Director will be effective in collaborating within the organization and provide leadership by communicating, executing, and providing guidance to team members toward achieving the department / corporate objectives.

Essential Functions :

• Lead the development of CMC regulatory strategy for assigned clinical-stage programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project / product life cycle.
• Serve as the regulatory representative at internal CMC team meetings, core submission meetings, and other cross-functional meetings.
• Provide Regulatory Affairs-CMC strategic guidance to project teams and ensure timely development and execution of robust global regulatory strategies, regulatory risk assessments, and mitigation plans.
• Assess and communicate CMC regulatory requirements to ensure all global development activities comply with applicable regulations and guidelines in each jurisdiction.
• Initiate and lead discussions with health authorities to proactively obtain scientific advice / agreement and resolve CMC issues in a timely manner.
• Facilitate the preparation for CMC-focused meetings with FDA, EMA, PMDA, or national competent authorities, and participate in or lead the interactions with these agencies.
• Support Quality and CMC team(s) during GMP inspections.
• Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and CMC regulatory submissions (e.g., original INDs, CMC amendments, IMPD Amendment, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development.
• Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success.
• Provide regulatory review and input on core product development documentation (e.g., stability protocols and reports, method or process validation protocols and reports, specifications, technical assessments, etc.).
• Provide input on project related budgets and ensure projects operate within capital and expense budget guidelines.
• Coordinate and conduct global CMC regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, Product Development Team Lead, or executive management, as required.
• Keep appraised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities.
• Coordinate with appropriate team members and stakeholders to resolve outstanding CMC regulatory issues.

Requirements :

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Ironwood currently anticipates that the initial base salary for this position could range from between $202,000 to $236,040. The actual base salary will depend, in part, on the successful candidate’s 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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Salary : $202,000 - $236,040