Regulatory Affairs Expert
hace 2 semanas
Job Summary:
Ironwood Pharmaceuticals seeks a seasoned Regulatory Affairs expert to lead our CMC function, ensuring compliance with global health authority regulations and guidelines. As Head of Regulatory Affairs-CMC, you will develop and execute a strategic regulatory plan to support product development and commercialization.
Key Responsibilities:
- Lead the CMC Regulatory Affairs function, setting the long-term regulatory strategy for all products throughout all phases of the product life cycle.
- Provide Regulatory Affairs-CMC guidance to project teams, ensuring timely development and execution of robust global regulatory strategies, risk assessments, and mitigation plans.
- Prepare and submit high-quality regulatory CMC submissions, collaborating with Technical Operations, Quality, and Regulatory Affairs functions.
- Work cross-functionally with Technical Development, Quality, and Regulatory Affairs colleagues to initiate and lead discussions with health authorities to obtain scientific advice/agreements and resolve CMC issues.
- Lead regulatory CMC intelligence activities, providing counsel, training, and interpretation of FDA, EMA, and other health authority feedback, policies, and guidelines.
- Develop and implement fit-for-purpose policies, procedures, and systems to ensure compliance with CMC regulatory requirements in regulatory regions of interest for all products throughout all phases of the product life cycle.
Requirements:
- Bachelor's degree in a Life Sciences discipline or equivalent, advanced degree preferred.
- 10-15 years of biopharmaceutical experience with at least 5-10 hands-on Regulatory Affairs-CMC experience and at least 5-10 years managing direct reports.
- Thorough understanding of relevant regulations and guidelines, including ICH, FDA, and EMA guidelines, for the development of small molecule drugs, biologics, and drug-device combination products.
- Strong knowledge of current Good Manufacturing Practices (GMP).
- Strategic thinking with strong analytical and project execution skills.
- Detail-oriented and results-driven with strong written, verbal communication, and presentation skills.
Company Overview:
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.
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