Director, Regulatory Affairs-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. 

Reporting to the Head of Regulatory Affairs CMC, the Director of Regulatory Affairs chemistry, manufacturing and controls (CMC) is responsible for coordinating all aspects of CMC regulatory submissions. This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role also exercises strategic approaches for Health Authority filings and communications. Manages relevant submissions to US investigational new drug applications (IND), ex-US clinical trial applications, new drug applications (NDAs), biological license applications (BLAs), and marketing authorization applications (MAAs). This role works closely with the Pharmaceutical Development and Manufacturing Sciences (PDMS), Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project teams.

Responsibilities:

• Coordinate CMC-related submissions to regulatory authorities and track progress of submission, review, and approval, including submissions across multiple countries and clinical studies. Coordinate responses to questions. Ensure appropriate archiving of documentation.
• Support cross-functional project teams on core Module 3 development, writing, and appropriate updates. Facilitate transition of core Module 3 documents to regional format (e.g., IMPD, QOS).
• Review chemistry, manufacturing, and controls-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and as appropriate for the phase of development; will be required to provide relevant content or develop documents and templates, as necessary.
• Track and manage regulatory actions associated with post-approval and development stage changes through completion.
• Liaise internally with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs.
• Ensure continued regulatory compliance through adherence to change control procedures and completion of regulatory impact assessments.
• Monitor CMC regulations and guidance to assess relevant changes and implications to current and future development and commercial activities.
• Work with cross-functional teams to identify and support continuous improvement opportunities for processes and systems.
• Provide strategic and forward-looking guidance regarding processes and systems.
• Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency commensurate with departmental and company growth.
• Provide leadership within the Regulatory department, identifying and managing through completion of departmental and cross-project initiatives and regulatory obligations.
• Liaise internally with members of functional departments.
• Liaise externally with vendors, partners, and joint development collaborators.

Qualifications:

• BS/BA Degree in a Scientific Discipline; Advanced Degree preferred.
• 10 years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
• Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up or regulatory registration of products is required.
• Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Demonstrate leadership, problem-solving ability, flexibility and values teamwork.
• Exercise good judgment in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
• Excellent communication and interpersonal skills.
• Work well with employees across the entire organization.
• Demonstrated skills managing project timelines and organizing supporting resources.
• Solid working knowledge of drug development process and in-depth knowledge of FDA and EU regulatory requirements; Japan, China, and ROW experience desirable.
• Strong knowledge of Good Manufacturing Practices (cGMP).

Ironwood currently anticipates that the initial base salary for this position could range from between $197,000 to $229,320.  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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