Vacancy for Senior Regulatory Affairs Associate at PAREXEL
PAREXEL has supported the Bio-Tech and Pharmaceutical
industries in helping the development of new drugs and treatments on a global
basis. As a leading global biopharmaceutical service provider, they supply
knowledge-based contract research, medical communications and consulting
services across a broad range of therapeutic areas to the worldwide
pharmaceutical, biotechnology and medical device industries.
Post : Senior Regulatory Affairs Associate
Job Description
• Good understanding of regulatory framework, including
regional trends, for various types of applications and procedures for small and
large molecules across all regions as well as knowledge of global
pharmaceutical legislation and guidance specifically linked to regulatory CMC
aspects in the ICH countries . Experience with ROW countries would be a plus.
• Lead and / or contribute to the planning, preparation
(including authoring where relevant) and delivery of simple, and with
experience, increasingly more complex regulatory maintenance submissions from
either a global and/or regional perspective.
• Liaise closely with cross-functional members with aligned
product responsibilities.
• Develop, execute and maintain submission delivery plans, submission
content plans, and proactively provide status updates to designated
stakeholders.
• To prepare, review and submit safety variations to Health
Authorities and also perform post Approval CMC related updates (where
applicable)
• Ensure that the Regulatory Information Management system is
maintained and updated for all activities under role responsibility, including
review of documents
• Prior working experience in Regulatory Information
Management Systems like Veeva Vault would be desirable
Candidate Profile
Bachelors/ Masters in Pharmacy OR Bachelors/ Masters in any
of Life Sciences
Join for Regular Job Updates in What's App & Telegram
No comments:
Post a Comment