Regulatory CMC Manager

Overview

Helsing Healthcare SA is looking for a skilled Regulatory CMC Manager to join our Regulatory Affairs team in Lugano.

In this role, you will ensure compliance, quality, and excellence in our global regulatory submissions – with a particular focus on authoring CMC documentation and managing the Module 3 at an expert level.

What we are looking for

• Solid proven experience in Regulatory CMC within the pharmaceutical industry
• Expertise in authoring and reviewing Module 3 (initial registrations or post-approval variations) (essential)
• Strong CMC knowledge with hands-on involvement in preparing and managing CMC documentation for regulatory submissions
• Good knowledge of CMC lifecycle maintenance activities across EU and international markets
• Degree in Pharmacy, Life Sciences, or related technical discipline; postgraduate in Regulatory Affairs or Pharmaceutical Sciences is an advantage
• Strong understanding of GMP and pharmaceutical quality systems
• Knowledge of ICH guidelines (Q8, Q9, Q10, Q11, Q12) and their practical application
• Fluency in English (written and verbal) – essential
• Experience on injectables and API (small molecules) desirable

What you will do

Regulatory CMC

• Write, review, and adapt CMC sections of dossiers for global regulatory submissions (Modules 2.3 and 3)
• Manage CMC documentation across multiple territories, ensuring compliance with local requirements
• Participate in change control processes to assess the regulatory impact of proposed changes to products, manufacturing processes, or facilities.
• Track and evaluate the impact of the CMC changes across different markets.
• Collaborate closely with Global Regulatory Leads to align CMC activities with the global regulatory strategy
• Lead the preparation and review of the CMC documentation, including the adaptation of CMC sections to meet the specific regulatory requirements of various territories.
• Handle complex submissions and provide hands-on support to critical projects

GMP & Regulatory Quality Assurance

• Oversee compliance with regulatory requirements for manufacturing, packaging, testing, and distribution activities
• Ensure alignment between registered CMC information and manufacturing operations
• Review and approve GMP-related documentation from a regulatory perspective
• Support QA during inspections, audits, and Health Authority interactions

Cross-functional collaboration

• Work closely with Quality, CMC, Supply Chain, R&D, and Commercial teams to provide regulatory CMC guidance
• Collaborate with Helsinn affiliates, partners, and global RA leaders to align strategies and submissions
• Plan, coordinate, oversee, and actively support the preparation and submission of CMC documents for new Marketing Authorisation Applications (MAAs), variations, renewals, and other post-approval activities in the territories assigned, according to the global strategies

Compliance & Continuous Improvement

• Monitor regulatory changes impacting CMC and manufacturing activities
• Support changes and process improvements from a regulatory perspective
• Support updates to internal SOPs and continuous improvement projects

What we value

• Strategic and analytical mindset with a hands-on approach
• Excellent communication skills, able to translate technical concepts for diverse stakeholders
• High attention to detail and commitment to regulatory excellence
• Ability to manage multiple projects and deadlines in a dynamic environment
• Adaptability to changing priorities and requirement

Location

Lugano, Switzerland – Regulatory Affairs Department

At Helsinn, we combine a global footprint with a family-owned culture , driven by innovation and patient care. If you are ready to bring your Regulatory CMC expertise and Module 3 knowledge to an international and collaborative environment, we would love to hear from you.

Apply now and join us in shaping the future of therapies worldwide!

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