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 functions 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:

• Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred, but not required.
• Minimum of 10 years of increasing responsibility in Regulatory Affairs Global CMC within the biopharmaceutical industry.
• Candidates must have proven strategic development capabilities related to new drug development and commercial support activities.
• Demonstrated recent successful global Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the EU and internationally. Rare disease and pediatric drug development experience is highly desirable.
• Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies.
• Must have strong communication and interpersonal skills needed to influence internal stakeholders in a diplomatic manner to ensure project success.
• Demonstrate excellent teamwork and communication skills with the ability to impact and influence the decisions of a team.
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
• Good oral and written communication, time management, and team-oriented leadership skills are essential.
• Strong oral and written communication, time management, and team-oriented leadership skills are essential.
• Excellent computer and project management skills are essential for the successful candidate.
• Ability to work in a fast paced environment and to handle multiple tasks.

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