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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