Global Regulatory Affairs Lead, Diagnostics & Strategy

Roche; Branchburg Township (NJ); On-site; USD 106,000 - 197,000; Full time

Job summary

Roche Global Regulatory Affairs seeks a professional to oversee regulatory documents and submissions for complex products, interfacing with external stakeholders and driving global regulatory strategies. The role involves leading cross-functional collaboration and adapting to evolving regulatory landscapes.

You will work with international regulators and internal teams to accelerate approvals while ensuring compliance.

Qualifications

• Bachelor’s/Master in Life Science, Data Science or related field; advanced degree preferred.
• 3–5 years with PhD, 5–7 with Masters, 6–8 with Bachelor in IVDs/Medical devices/Pharma/Biopharmaceuticals; regulatory affairs experience considered an advantage.
• Knowledge of Daily Management and Continuous Improvement best practices.
• Familiarity with European, US, China and other international regulations; ability to interpret and implement quality standards.

Responsibilities

• Oversee regulatory document and submission compilation for complex products and global registrations.
• Interface with external management; build relationships and manage stakeholder needs; support audits.
• Lead organizations to adapt to evolving regulatory environments and influence strategies for worldwide approvals.
• Partner with external and internal stakeholders to address problems and opportunities; drive solution-oriented initiatives.

Skills

Regulatory leadership

Stakeholder management

Continuous improvement

Decision making

Education

Bachelor’s/Master in Life Science or related

Advanced degree preferred

Job description

Roche Global Regulatory Affairs seeks a professional to oversee regulatory documents and submissions for complex products, interfacing with external stakeholders and driving global regulatory strategies. The role involves leading cross-functional collaboration and adapting to evolving regulatory landscapes.

You will work with international regulators and internal teams to accelerate approvals while ensuring compliance.