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.
Important Vacancy details:
- Post Name: Associate, GRA – PLCM (US, Canada, ROW)
- Education:M. Pharm or other equivalent health science, scientific qualification
- Experienced:5+ years Regulatory Affairs experience (Licence Maintenance / Product Life cycle Management) in Prescription Medicines preferably in US, Canada, International markets
- Location:Mumbai, MH, IN, 400079
- Salary: NA
- Openings: NA
Job Description: Hiring For Associate, GRA – PLCM (US, Canada, ROW) in Apotex Inc!
Responsible for the product life cycle management of Apotex products (Toronto) in identified markets (US, Canada, International markets etc.).
- Responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.
- Responsible for the preparation of quality regulatory PLCM submissions for various markets to ensure timely approval.
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
- Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.
- Works with other functional areas to resolve issues related to information for regulatory submissions.
- Responsible for handling the Supplier driven changes (SDC). This involves activities such as evaluate, prepare & review of SDC related assessments.
- Evaluate, prepare and review of post approval supplements to manage the regulatory product life cycle as applicable.
- Review of change control documents.
- Approval of change control documents and quality notifications as assigned.
- Maintains regulatory databases to ensure accuracy of information.
- Perform additional duties as assigned by RA Manager.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion, Demonstrates strong and visible.
- 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