Global Regulatory Affairs Manager – Diagnostics & Submissions

Roche Holding AG; Indianapolis, Northern (IN, KY); Hybrid; USD 106,000 - 197,000; Full time

Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Roche Holding AG is seeking a regulatory affairs professional to advance submissions for complex diagnostics programs with global scope. You will compile regulatory documents, manage submission plans, and interact with external stakeholders to accelerate approvals.

You will navigate evolving global regulations, shape regulatory strategies, and collaborate across functions to ensure compliant, timely registrations in multiple regions.

Qualifications

• Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
• 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs
• Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
• Demonstrated ability to manage more complex work and/or at parts of global projects.

Responsibilities

• Oversee regulatory document and submission compilation, including development of submission/product registration dossiers for more complex products/programs.
• Interface with external management; communicate needs of external customers/stakeholders and support audits.
• Lead the organization to adapt to evolving regulatory environment and requirements; apply regulators' thinking to projects and regions.
• Partner with external and internal stakeholders to understand needs and provide best solutions; influence current and future direction.
• Show courage to make decisions outside scope and proactively initiate activities independently.
• Model VAAC Leadership and agility; develop VACC competency and foster an inclusive environment.
• Pull people together around a common goal and resolve conflicts with openness and trust.

Skills

Regulatory Affairs

Daily Management

Continuous Improvement

Global Regulations

Education

Bachelor’s or Master in Life Science or related

Advanced degree preferred

Job description

Roche Holding AG is seeking a regulatory affairs professional to advance submissions for complex diagnostics programs with global scope. You will compile regulatory documents, manage submission plans, and interact with external stakeholders to accelerate approvals.

You will navigate evolving global regulations, shape regulatory strategies, and collaborate across functions to ensure compliant, timely registrations in multiple regions.