Director, Global Regulatory Affairs Cmc
vor 4 Wochen
Join Takeda as a Director, Global Regulatory Affairs (GRA) CMC, where you will lead GRA CMC Due Diligence in partnership with organizational and external stakeholders. You will ensure the communication/development of regulatory CMC risks and strategy, develop best practices that enable CMC due diligence, ensuring that a given compound meets technical and quality elements to allow for successful commercialization of the drug. This role serves as a key strategic partner with Pharmaceutical R&D and works closely with the broader Regulatory Matrix Team to conceive and deliver innovative regulatory strategies for seamless integration of CMC activities. As part of the Global Regulatory Affairs CMC team, you will report to the Head of Global Regulatory Affairs CMC - Marketed Products, CMC Sourcing and Due Diligence and partner closely with Pharmaceutical Sciences, Global Manufacturing Services.
**How You Will Contribute**
- Demonstrate Takeda leadership behaviors.
- Represent Global Regulatory Affairs CMC on due diligence teams to evaluate new business development opportunities.
- Develop best practices for robust regulatory CMC due diligence, understanding and clearly communicating on potential and actual risks
- Develop a team of experts to enable seamless due diligence through active engagement with stakeholders and establishing effective practices.
- Interpret applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC best practice and compliance.
- Manage and support staff, if required, including staff professional development and project oversight.
- Build and manage relationships through active partnering with key internal (GRA, GRA CMC, Pharm Sci, GMS, GQ etc.) and external stakeholders
- Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
**Minimum Requirements/Qualifications**
- Bachelor's Degree in a Scientific Discipline with 10+ years of relevant professional experience.
- Broad understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Extensive experience with global API and Drug Product regulatory CMC requirements for drugs, biologics, and combination products through lifecycle.
- Direct experience in writing/reviewing regulatory CMC source and submission documents and demonstrated ability to evaluate program risk and submission risk from a regulatory standpoint.
- Experience providing strategic regulatory guidance to drug development, and registration support teams.
- Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
- Good judgement in elevating and communicating actual or potential issues to line management.
- Excellent written and oral communication skills.
**Travel Requirements**:
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
**Locations**:
Zurich, Switzerland
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
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