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Takeda Lexington, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Takeda Pharmaceutical Company Ltd Lexington, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
Associate Director, Regulatory Affairs CMC - Lexington, United States - Accede Solutions Inc.
Description
Hybrid Role
The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products.
This position will oversee CMC Health Authority submissions, collaborating across the business and with external partners to develop submission content and strategy.
Responsibilities:
Ensures high-quality and on-time submissions, including for INDs, IMPDs, CTAs and BLAs, that align with company strategies and Health Authority requirements.
Coordinate responses to CMC-related inquiries from regulatory agencies with thorough submission management
Support preparation for Health Authority CMC meetings and development of meeting information packages
Provide regulatory and scientific expertise to review CMC source documentation in support of dossiers.
Develops relationships with and proactively communicates issues with key internal colleagues.
Develops and implements best practices based on current and emerging industry trends, and relevant Health Authority guidance and regulations.
Basic Requirements:
Bachelor of Science in a scientific discipline, advanced degree preferred
6+ years biopharmaceutical experience with a CMC focus
At least 3 years Regulatory CMC biopharmaceutical experience, biologics experience required
Proven ability to manage projects. Capable of performing independently and thinking analytically and creatively to solve problems.
Excellent oral and written communication
Willingness to work through change and work toward continuous improvement
Experience in writing and developing documents with scientific content for IND and BLA submissions in eCTD format
Knowledge of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as it relates to regulatory requirements for assessing changes throughout development,
Understanding of scientific principles and capable of interpreting regulatory requirements.
Preferred Requirements:
Understanding of regulations and guidance (examples: CFR, FDA guidance, EU, ICH, Health Canada, ISO)
Direct experience participating in regulatory interactions with health authorities
Ability to influence decisions with effective communication skills
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