16 ott - Siena
We make it
Global Regulatory Affairs Associate
We make it GmbH is a company operating nationally in Switzerland. Thanks to many years of successful experience, it has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.
For our customer, the company CSL Seqirus, are we searching for:
Description
CSL Seqirus is one of the world’s largest influenza vaccine companies, specializing in the development and manufacture of vaccines to help prevent influenza. The company uses both egg-based and cell-based technologies and has extensive research and production expertise. Its manufacturing facilities are located in the United States, the United Kingdom and Australia. CSL Seqirus is also a global leader in influenza prevention and a key partner in pandemic preparedness. Every year, its influenza vaccines help protect millions of people from seasonal influenza.
Work hours
Standard 41h / Week
Duration
6 Months
Tasks
- Lead and execute regulatory strategies for assigned products and projects
- Prepare, compile, and submit highquality regulatory applications, including variations, renewals,
and responses to health authority questions
- Ensure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets
- Provide regional regulatory expertise to support global development, CMC, compliance, and labeling activities
- Liaise with regulatory authorities and support regulatory agency interactions
- Collaborate with cross-functional stakeholders including Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations, and Business Development teams
Qualifications
- Degree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred)
- Minimum 5+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry
- Strong experience with regulatory submissions and registrations in the EU, UK, and Switzerland
- Experience managing regulatory applications, variations, renewals, and health authority interactions
- Exposure to Veeva and regulatory application management systems is highly desirable
- Experience in vaccines and/or biologics is advantageous
- Strong project management, stakeholder management, and communication skills
- English proficiency is required as all Seqirus business is conducted in English
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