Apotex Inc Recruitment November 2020.Apotex Inc Notification full detailes below.Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world.
Importan Vacancy details:
- Post Name: Sr. Associate, Regulatory Affairs, Co-Development, US & Canada
- Education:M. Pharm/MSc or other equivalent health science, scientific qualification
- Experienced:5-7 years Regulatory Affairs experience in solid orals and injectables dosage forms
- Location: Bangalore, KA, IN
- Salary: NA
- Openings: NA
Job Description: Hiring For Sr. Associate, Regulatory Affairs, Co-Development, US & Canada in Apotex Inc
Review, compile and collate the Co-development dossiers (like generic applications, query responses and supplements/variations) for regulatory authorities like USFDA and Health Canada. Should have experience in Injectables and solid oral dosage forms filings.
- Review and compilation of Injectable applications (i.e., ANDA, NDA and ANDS) for drug product registration with Health authorities of regulated markets.
- Responding to related queries received from regulatory bodies.
- Review of all technical documents required for submissions and deficiency responses.
- Preparation and review of supplements/variations (CBE, CBE-30, PAS, sANDS and Level -III) for Injectables (co-development) and solid oral dosage forms (ARPL) to Health authorities of regulated markets
- Relevant communication and follow ups with respective internal departments/CROs/CMOs required for compilation, submission, query responses and change controls.
- Review and maintenance of change controls and customer notifications related to the Co-development projects.
- Works as a member of a team to achieve all outcomes.
- Perform all work in support of our values of Collaboration, Courage, Passion and Perseverance; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- All other duties as assigned.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online