Apotex Hiring Associate, GRA – PLCM M. Pharm or other equivalent health science, scientific qualification
Job Summary
Responsible
for the product life cycle management of Apotex products (Toronto) in
identified markets (US, Canada, International markets etc.).
Job Responsibilities
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.
Job
Requirements
M.
Pharm or other equivalent health science, scientific qualification
5+
years Regulatory Affairs experience (Licence Maintenance / Product Life cycle
Management) in Prescription Medicines preferably in US, Canada, International
markets
Good
verbal & written communication, organizational and interpersonal skills.
TO APPLY CLICK HERE
Join for Regular Job Updates in What's App & Telegram
No comments:
Post a Comment