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
• 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
Bachelors/ Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences
Qualification : M.Pharm, M.Sc OR B.Pharm, B.Sc
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May, 2021
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