Regulatory Project Manager - Diagnostics

About the role

Roche is looking for a Regulatory Project Manager for its Diagnostics business. The role owns products from a regulatory affairs perspective for the assigned area of responsibility, obtains regulatory approvals in defined markets in close cooperation with other functions, and keeps approved products compliant throughout their life cycle. Relocation benefits are not available.

Key responsibilities

• Compile regulatory documents and develop submission and product registration dossiers for complex products, and mentor junior team members.
• Apply regulatory change controls to maintain approvals, permits and licenses over the product life cycle.
• Understand, communicate and implement regulatory requirements and strategies, keeping them up to date and transparent.
• Manage and influence stakeholders, including authorities, partners and external customers, and support audits.
• Act with autonomy, make timely decisions, and contribute to or lead projects that connect business functions, systems and data toward digitalization.
• Promote agile behaviors, data stewardship and regulatory tool usage, and improve processes across quality and research.

Required profile

• Bachelor's or Master's degree in Life Sciences, Data Science or a related field, or equivalent experience through technician or laboratory technician training.
• At least 5 years of experience (5-7 years preferred) in Regulatory, R&D, Quality, Operations and/or Clinical areas, with some healthcare regulatory affairs experience.
• Able to manage complex work and global projects; advanced degree is an advantage.
• Some business travel may be required.