Regulatory CMC Director
12 hours ago
At Upstream Bio, we are seeking an experienced Associate Director/Director, Regulatory CMC to lead our regulatory Chemistry, Manufacturing, and Controls (CMC) strategy for our biopharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements and support the development, approval, and commercialization of innovative therapies.
Key Responsibilities:- Regulatory Strategy and Submissions: Develop and implement global regulatory CMC strategies for product development and registration. Lead the preparation, review, and submission of high-quality CMC sections of regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs, etc.). Ensure alignment of CMC activities with overall regulatory strategy and project timelines.
- Regulatory Compliance: Monitor and interpret global regulatory CMC requirements and ensure compliance with applicable regulations and guidelines. Provide regulatory guidance to cross-functional teams, including R&D, Quality, Manufacturing, and Clinical teams. Lead the response to regulatory agency inquiries and deficiency letters related to CMC aspects of submissions.
- Cross-functional Collaboration: Collaborate with internal stakeholders to ensure CMC strategies align with overall product development plans. Represent the Regulatory CMC function in project team meetings and regulatory agency interactions. Provide regulatory input and support to manufacturing and quality teams during process development, validation, and commercial production.
- Documentation and Communication: Author, review, and approve CMC sections of regulatory submissions and related documents. Maintain accurate and up-to-date regulatory documentation and databases. Communicate regulatory CMC strategy, timelines, and risks to senior management and project teams.
Qualifications:
- BS or BA in scientific discipline
- Advanced degree (Ph.D., MS, or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field preferred
- 8-10 years of experience in regulatory CMC within the biopharmaceutical industry
- Proven track record of successful regulatory CMC submissions and product approvals
- In-depth knowledge of global CMC regulatory requirements and guidelines (FDA, EMA, ICH, etc.)
- Strong project management, organizational, and problem-solving skills
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively in a fast-paced, dynamic environment
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