Global Regulatory Strategy Leader for Complex Products
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Job summary
Roche is seeking a senior Regulatory Affairs leader to oversee global submissions for complex products and to steer registration strategies across major markets. In this onsite role, you will mentor junior staff, coordinate cross-functional teams, manage stakeholder relationships, and ensure compliance while accelerating worldwide approvals.
You will drive continuous improvement, influence external audits, and translate regulatory requirements into pragmatic plans, balancing speed and compliance
Qualifications
- Bachelor's, Master's or PhD in Life Science, Data Science or related field.
- Experience with Daily Management and Continuous Improvement best practices.
- Regulatory Affairs experience in IVDs/Medical devices/Pharma/Biopharmaceuticals.
- Strong knowledge of US/EU/international regulations and quality standards.
- Ability to manage highly complex/global projects and launches.
Responsibilities
- Oversee development of submission/product registration dossiers for complex products.
- Develop and manage global regulatory submissions and plans.
- Mentor junior team members and lead external initiatives.
- Cultivate health authority relationships and represent the company in audits.
- Drive regulatory strategies to accelerate worldwide approvals and ensure compliance.
Skills
Education
Tools
Job description
Roche is seeking a senior Regulatory Affairs leader to oversee global submissions for complex products and to steer registration strategies across major markets. In this onsite role, you will mentor junior staff, coordinate cross-functional teams, manage stakeholder relationships, and ensure compliance while accelerating worldwide approvals.
You will drive continuous improvement, influence external audits, and translate regulatory requirements into pragmatic plans, balancing speed and compliance
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