About this role

Perform labelling update and maintenance activities with respect to New Product Development
Interact with compilers for product allocated to understand any data related queries or data availability issues
Co-ordinate with the vendor/affiliates to ensure the timely creation and update of the artwork
Maintain all the trackers for label to ensure the timely submission of the labels to health authority
Responsible for coordination & preparation of regulatory submissions and Prepare and submit all the supporting documents for labelling submissions
Develop & maintain regulatory knowledge of Canada
Manage the final product submissions and negotiate and communicate effectively with regional team/regulatory authorities

2 years Masters in pharmacy with specialisation in Pharmacology
4 years Bachelors in Pharmacy
Compilation of dossier submissions via eCTD
Animal assays using dosing method, blood withdrawal techniques, oral dosing techniques
Molecular biology techniques: Gel electrophoresis, Plasmid and genomic DNA extraction, Transformation, Cloning and PCR
Sound knowledge of MS Office, Internet, email
An effective communicator with good presentation skills and organizational experience.

Accommodation for applicants with disabilities as part of its recruitment process

Senior Analyst, GBS GRA

Key skills