Global Regulatory Submissions & Compliance Lead

Roche; Sant Cugat del Vallès; On-site; EUR 45,000 - 65,000; Full time

Job summary

Roche is seeking a Regulatory Submissions professional to lead dossier preparation for moderate‑complexity products and to craft global submission plans for market access. You will apply knowledge of IVDR, FDA, and ISO 13485 frameworks to ensure compliant pathways and collaborate with internal teams and external regulators.

With 1+ years in Regulatory Affairs, QA, R&D, or Clinical Operations, you will use MS Office and EDMS/RIMS to manage documents, drive improvements, and support audits.

Qualifications

• University degree in Life Sciences, Biotechnology, Biomedical Engineering, Data Science, or related field (or equivalent practical experience).
• 1+ years of relevant experience within Regulatory Affairs, Quality Assurance, R&D, or Clinical Operations in healthcare or life sciences.
• Fluency in English (written and spoken) and proficiency with MS Office and EDMS/RIMS.

Responsibilities

• Lead and coordinate the preparation of registration dossiers for products and programs of moderate complexity.
• Formulate sound regulatory submission plans to secure market access globally.
• Apply knowledge of global regulations to establish robust regulatory pathways for compliance.
• Cultivate enduring relationships with internal partners and external regulatory bodies.
• Champion continuous improvement and explore digital tools or automated workflows to drive efficiency.

Skills

Regulatory knowledge

Documentation

Communication

MS Office

EDMS/RIMS

Education

Bachelor's or Master’s in Life Sciences or related

Tools

EDMS/RIMS

Job description

Roche is seeking a Regulatory Submissions professional to lead dossier preparation for moderate‑complexity products and to craft global submission plans for market access. You will apply knowledge of IVDR, FDA, and ISO 13485 frameworks to ensure compliant pathways and collaborate with internal teams and external regulators.

With 1+ years in Regulatory Affairs, QA, R&D, or Clinical Operations, you will use MS Office and EDMS/RIMS to manage documents, drive improvements, and support audits.