Ironwood Pharmaceuticals - Director, Global Regulatory Affairs (GRA) - CMC
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Requirements
• Bachelor’s 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.
Responsibilities
• Lead the global CMC regulatory strategy across development, registration, and lifecycle management. • Serve as a single point for CMC regulatory lead on assigned programs. • Provide strategic guidance to project teams regarding Regulatory Affairs–CMC matters. • Assess and communicate global CMC regulatory requirements ensuring compliance with applicable regulations. • Initiate, manage interactions with health authorities (FDA, EMA, PMDA) for strategy alignment and approval support. • Lead the preparation of high-quality briefing packages and narratives for authority meetings.
Benefits
• Equity options available to employees as part of their compensation package. • Paid Time Off (PTO) is provided for vacations and personal time off. • Remote work options might exist; however, the posting does not provide explicit details on this benefit either.
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