Regulatory Specialist, CMC — Post‑Marketing & Remediation (12M)

Work Selection AG; Basel; On-site; CHF 110,000 - 140,000; Full time

Benefits offered by this job

Modern tools & tech

Diversity & inclusion

Professional development support

Staff restaurants

On-site parking

Welcome Days

Job summary

Roche Basel is seeking a Regulatory Specialist (CMC) for a 12-month assignment to manage global regulatory submissions for commercial products, focusing on post-approval maintenance and remediation of legacy data. You will collaborate with cross-functional teams to ensure continued regulatory compliance across markets.

The role requires a Bachelor’s degree and 3–4 years of CMC/regulatory experience, strong Veeva RIM proficiency, and fluent English (C1).

Qualifications

• Minimum Bachelor’s degree in a relevant field.
• 3–4 years of CMC regulatory / technical regulatory experience.
• Experience with post-approval / post-marketing regulatory maintenance.
• Experience with regulatory change controls.
• Experience managing or supporting regulatory deviations.
• Proficient with Veeva RIM and regulatory submissions.
• Fluent English, written and spoken, C1 level.
• Proactive problem-solving ability to streamline legacy records.

Responsibilities

• Independently manage and execute global technical regulatory submissions for commercial products.
• Manage regulatory lifecycle of assigned commercial products.
• Assess technical change records for regulatory impact and coordinate post-approval activities.
• Support post-marketing submissions, change controls and regulatory deviations.
• Maintain and remediate CMC documentation in Veeva RIM.
• Support system integration and cleanup of legacy regulatory information.
• Represent PTR on cross-functional project teams and provide regulatory advice.
• Collaborate with local and global teams to ensure ongoing regulatory compliance.
• Interact with Health Authorities and partners on technical topics.
• Identify regulatory risks and improve tracking and workflows.

Skills

English proficiency

Regulatory experience

Problem solving

Team collaboration

Regulatory change controls

Lifecycle management

Education

Bachelor's degree

Tools

Veeva RIM

Regulatory submissions

Job description

Roche Basel is seeking a Regulatory Specialist (CMC) for a 12-month assignment to manage global regulatory submissions for commercial products, focusing on post-approval maintenance and remediation of legacy data. You will collaborate with cross-functional teams to ensure continued regulatory compliance across markets.

The role requires a Bachelor’s degree and 3–4 years of CMC/regulatory experience, strong Veeva RIM proficiency, and fluent English (C1).