Regulatory Specialist

Flexsis; Basel-Stadt; On-site; CHF 90,000 - 130,000; Full time

Job summary

Flexsis is seeking a Regulatory Specialist (m/f/d) based in Basel, Switzerland for a 12‑month contract with extension potential. The role focuses on commercial products, post‑marketing activities and data remediation, supporting global regulatory submissions and lifecycle management.

You will work with global technical teams to ensure compliant documentation, lead legacy data clean‑up and improve data quality using Veeva RIM, while coordinating risk assessments and change controls across

Qualifications

• Bachelor's degree or higher in a scientific, pharmaceutical or technical field.
• 3–4 years of experience in CMC Regulatory or Technical Regulatory affairs.
• Experience supporting commercial products and post-approval activities.
• Proficiency with change controls and regulatory deviations.
• Fluent English, written and spoken (C1).

Responsibilities

• Manage global CMC regulatory activities for commercial products.
• Support post-approval submissions and lifecycle management.
• Assess regulatory impact of changes and manage change controls.
• Review and remediate legacy regulatory data with documentation.
• Maintain regulatory information in Veeva RIM and related systems.
• Collaborate with international teams and external partners.

Skills

English (C1)

Analytical skills

Problem solving

Independent work

Education

Bachelor's degree or higher in a scientific field

Tools

Veeva RIM

Regulatory systems

Job description

Regulatory Specialist (m/f/d) – Commercial / Post-Marketing & Remediation

For our client, an internationally renowned company in the pharmaceutical and healthcare industry, we are looking for a Regulatory Specialist (m/f/d) with a focus on commercial products, post-marketing activities and regulatory data remediation. This is a full-time position based in Basel, Switzerland, with an initial contract duration of 12 months and a likely possibility of extension. The ideal candidate would be available to start as soon as possible, with 1 February 2027 being the latest possible start date.

About the Role

In this role, you will support the regulatory lifecycle management of commercial pharmaceutical products, ensuring that product information, regulatory records and technical documentation remain accurate, complete and compliant. You will contribute to post-approval submissions, change control activities and the remediation of legacy regulatory data, working closely with global technical teams and cross-functional stakeholders.

Key Responsibilities

• Manage and coordinate global CMC regulatory activities for commercialized pharmaceutical products.
• Support post-approval regulatory submissions and ongoing product lifecycle management.
• Assess the regulatory impact of technical changes and manage change control processes.
• Review, investigate and manage regulatory deviations, ensuring appropriate documentation and follow-up.
• Perform legacy data clean-up, including the review, reconciliation and updating of historical product information and regulatory records.
• Maintain accurate and compliant regulatory information within Veeva RIM and related document management systems.
• Support system integration, data harmonization and remediation initiatives.
• Identify inconsistencies, potential compliance risks and gaps in regulatory documentation, and develop practical solutions.
• Collaborate with global technical teams, regulatory stakeholders and external partners to ensure compliance with applicable requirements.
• Monitor relevant regulatory guidelines and assess their impact on commercial products and lifecycle activities.
• Identify opportunities to simplify workflows, improve data quality and increase operational efficiency.

Your Profile

• Bachelor's degree or higher in a relevant scientific, pharmaceutical or technical discipline.
• 3–4 years of professional experience in CMC Regulatory Affairs or Technical Regulatory Affairs.
• Experience supporting commercial pharmaceutical products and post-approval regulatory activities.
• Practical experience with change controls, regulatory deviations and product lifecycle management.
• Strong proficiency in Veeva RIM and experience managing regulatory information and documentation.
• Experience with legacy product data clean-up, data remediation or regulatory system integration.
• Solid understanding of global regulatory requirements and pharmaceutical compliance standards.
• Fluent in English, both written and spoken (minimum C1 level).
• Strong analytical and problem-solving skills, with a proactive and solution-oriented mindset.
• Ability to work independently, manage complex data and documentation, and collaborate with international stakeholders.

Nice to Have

• Experience with biologics.
• German language skills.