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Regulatory CMC Specialist: Drive Compliance & Dossiers
Descrizione del lavoro
A leading biopharma company in Toronto is seeking a Specialist in Regulatory Chemistry, Manufacturing, and Controls (CMC) to maintain high-quality regulatory documents. The ideal candidate has a BSc. and experience in Regulatory Affairs CMC, along with strong knowledge of CMC regulations. This role emphasizes attention to detail and innovative thinking while working in a supportive team environment. Health and wellness benefits are included.
Servizi
Competenze
- 1 year of experience in Regulatory Affairs CMC.
- Working knowledge of CMC regulations and Health Canada guidelines.
- Solid understanding of manufacturing processes.
Mansioni
- Maintain high quality local Regulatory CMC documents.
- Perform compliance review of change controls.
- Support CMC submission dossier and local regulatory documents.
Conoscenze
Formazione
Strumenti
* Il benchmark retributivo si basa sugli obiettivi retributivi dei leader del mercato nei rispettivi settori. È pensato per orientare gli utenti Premium nella valutazione delle posizioni aperte e aiutarli a negoziare la propria retribuzione. Tale benchmark non è fornito direttamente dall'azienda, quindi la retribuzione effettiva potrà risultare anche notevolmente superiore o inferiore.