Regulatory CMC Manager (Expert in Module 3 submissions)
Info azienda.
Helsinn 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.
Competenze richieste.
🔑 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
- Experience on injectables and API (small molecules) - desiderable
- 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
Saranno richiesti i seguenti compiti.
🌍 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
Che cosa offriamo.
💡 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 requirements
📍 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!
Tipologia di contratto
Contratto a tempo indeterminato
Lingue richieste
Inglese professionale
Domande specifiche per la candidatura
Rispondere alle domande per migliorare la propria candidatura
Do you have proven hands-on experience in compiling and reviewing Module 3 (Quality) in English for regulatory submissions?
Have you been directly involved in assessing the regulatory impact of Change Controls (e.g., manufacturing process changes, new suppliers, facility updates)?
Do you have direct Regulatory CMC experience with APIs (small molecules) for injectable products?
In which markets have you been directly involved in submitting Regulatory CMC dossiers?
IMPIEGO 100% full time
Regulatory CMC Manager (Expert in Module 3 submissions)
