Regulatory Specialist; CMC Commercial Products, Lifecycle Management & Remediation

For our client, we are seeking an experienced Regulatory Specialist (CMC) to support commercial products and post-approval regulatory activities. The focus of this role is lifecycle management, regulatory compliance, change controls, deviations, remediation projects, and maintenance of regulatory records within global systems.

This position is ideal for candidates with strong experience supporting marketed pharmaceutical products in highly regulated international environments.

Contract Duration: 12 months

Extension: Likely

Start Date: ASAP

Latest

Start Date:

February 1, 2027

Department: Pharma Technical Regulatory (PTR)

• Manage global CMC regulatory submissions and post-approval activities for commercial products.
• Evaluate technical changes and determine regulatory impact.
• Manage change controls, regulatory deviations, and maintenance submissions.
• Maintain and update regulatory documentation within Veeva systems.
• Support remediation projects, legacy data reviews, and regulatory record clean-up initiatives.
• Ensure ongoing compliance with global and regional regulatory requirements.
• Serve as the primary regulatory representative within cross-functional project teams.
• Identify regulatory risks and develop practical mitigation strategies.
• Collaborate with manufacturing, quality, supply chain, and regulatory stakeholders globally.
• Drive process optimization and operational excellence initiatives.
• Monitor evolving regulatory requirements and assess business impact.

• Bachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related scientific discipline.
• Minimum 3–4 years of experience in CMC Regulatory Affairs or Technical Regulatory Affairs.
• Strong experience supporting commercial pharmaceutical products.
• Proven experience with post-approval maintenance and lifecycle management.
• Experience with change controls, regulatory deviations, and variations.
  
  Strong knowledge of Veeva RIM and regulatory information management systems.
• Experience working with regulatory remediation and data clean-up initiatives.
• Ability to work independently and manage multiple priorities simultaneously.

• Experience with biologics.
• Previous Roche experience or experience within a large global pharmaceutical company.
• Knowledge of international regulatory frameworks and submission processes.
• German language skills are considered an advantage.

We are looking for hands-on Regulatory Affairs professionals who can contribute immediately within a global pharmaceutical environment. Successful candidates combine strong CMC expertise, practical Veeva experience, a proactive mindset, and the ability to navigate complex regulatory challenges while collaborating effectively with global stakeholders.