Regulatory Specialist - Commercial / Post-Marketing & Remediation (CMC)

About the role

Work Selection AGA, a first-tier supplier to F. Hoffmann-La Roche Ltd. in Basel, is hiring a Regulatory Specialist (Commercial / Post-Marketing & Remediation, CMC) for a 12-month temporary assignment. You will support technical regulatory activities across the lifecycle of commercialised pharmaceutical products, focusing on post-approval regulatory maintenance, change controls, regulatory deviations, system integration and remediation of legacy regulatory data and records.

Key responsibilities

• Independently manage and execute global technical regulatory submissions for commercial products, in line with local and regional registration requirements, internal policies and audit standards.
• Manage the regulatory lifecycle of assigned commercial products and assess technical change records for regulatory impact.
• Coordinate post-approval regulatory activities, support post-marketing submissions, change controls and regulatory deviations.
• Maintain and remediate CMC regulatory documentation and data in Veeva RIM and related document management systems.
• Support system integration and clean-up of legacy regulatory information.
• Represent Pharma Technical Regulatory on cross-functional project teams, advise colleagues and interact with Health Authorities and external partners.
• Identify regulatory risks and monitor changes in global regulatory requirements.

Required profile

• Minimum Bachelor's degree in a relevant field.
• 3-4 years of CMC regulatory / technical regulatory experience.
• Experience supporting commercialised pharmaceutical products and post-approval regulatory maintenance.
• Experience with regulatory change controls and regulatory deviations.
• Experience with legacy product data clean-up and remediation.
• Fluent written and spoken English (minimum C1).
• Nice to have: German, previous Roche experience, experience with biologics.

Required skills

• Strong proficiency in the Veeva RIM environment.
• Experience maintaining regulatory submission documentation in Veeva.

What we offer

• Modern tools and an inclusive work culture.
• Financial support for professional development plans.
• Year-round discounts at retailers and over 200 brands, plus fleet and fuel card discounts.
• State-of-the-art campus with fitness and swimming pool facilities, staff restaurants and on-site parking.
• Welcome Days onboarding.