RA Principal Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8iaqb6

RA Principal Associate (M/F/X)

Verifichi che le sue competenze e la sua esperienza corrispondano ai requisiti di questo ruolo, quindi si candidi con il suo CV qui sotto.
Tasks:

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- Lead and execute regulatory strategies for assigned products and projects.
- Prepare, compile, and submit high-quality 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.

Qualification:

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- 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. xysqume
- Strong project management, stakeholder management, and communication skills.
- English proficiency is required as all Seqirus business is conducted in English

Requirements:
Start: Within the next four weeks

Duration: 6 months

Capacity: 5 days per week

Location: Tuscany (IT)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8iaqb6