21 ott - Siena
We make it
Global Regulatory Affairs Associate
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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)
xysqume
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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