- Interfaces and partners cross-functionally within Global Regulatory Affairs Marketed Products (GRA-MP) and with senior management of CMC stakeholders (e.g. manufacturing, supply chain and quality) in development of life-cycle strategies for designated marketed products and for major global manufacturing initiatives. Responsible for effective and regular communication of strategy, issues and progress to all stakeholders.
- Accountable for regulatory CMC activities for designated marketed products. Interfaces with partner organizations to ensure CMC regulatory strategies are successfully executed. Ensures escalation procedures are followed and actively participates in the process.
- Interfaces within Global Regulatory Affairs Marketed Products (GRA-MP), GRA-CMC MP and GRA-CMC development colleagues to facilitate consistency in strategies, processes, and communication. Leads or supports process improvement workstream teams.
- Demonstrates leadership and comprehensive understanding of global regulatory CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to address and overcome challenges that arise. Demonstrates active leadership and engagement concurrent with activities.
- Provides CMC regulatory expertise for new business development/due diligence activities.
- Serves as GRA-CMC expert on senior-level cross-functional CMC stakeholder teams (e.g. site closure core teams) and applies and interprets applicable EMA/FDA/ICH/Global regulations to ensure robust strategies are developed.
- Ensures life-cycle management CMC activities for designated marketed products are executed, utilizing partner resources. Responsible for resolution of issues escalated by partner.
- Leads, ensures and/or enhances regulatory compliance of designated marketed products. Ensures regulatory CMC strategies are accurate, consistent and developed efficiently.
- Responsible for effective presentations to global, regional and/or local stakeholder teams and audiences. Is highly visible and engaged in these communications and are aligned with other ongoing regulatory activities such as routine product-specific updates and compliance initiatives.
- Responsible for effective and regular communication of strategy, issues and progress; and ensures timely and professional communication of developments that may impact regulatory success.
- Leads or supports preparation activities for Health Authority meetings and represents Takeda GRA-CMC in the meetings.
- Represents GRA-CMC in business process development activities or other regulatory initiatives within Global Regulatory Affairs Marketed Products.
- 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.
- Leads and/or supports new business process improvement workstream teams.
- Evaluates new business development opportunities or participate on due diligence teams.
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 8 + years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience.
- Experience with pharmaceutical development of active pharmaceutical ingredients or drug products, analytical characterization, process scale-up and/or regulatory registration of products is preferred.