- Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities
- Member of global project teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
- Leads, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.
- Manages and develops staff, if required, including staff professional development and project oversight accountability
- Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements
- Represents Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
- Interacts directly with international Health Authorities, as required. Participates in agency meetings and may facilitate, depending on experience.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner
- Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
- Evaluates change proposals for regulatory impact and filing requirements
- Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives
- Leads and/or supports new business process development activities
- Evaluate new business development opportunities or participate on due diligence teams
- RAC certification desirable but not mandatory
- Routine demands of an office based environment.
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