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 : Regulatory Affairs Consultant
• Expertise in CTD / eCTD submissions as well as Post Approval Activities: Licence Renewal, Variations etc for Regulated as well as Semi regulated markets.
• Well versed with Site Transfers, MA Transfers and related activities (especially for EU and US regions).
• Must able to handle Health Authority Query Responses as well as Gap Analysis prior submissions, Change Control management etc. from RA perspective.
• Exhibits good project management skills. Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes
• Typically works within a team environment but may work independently delivering services within their technical area of expertise=
• Proactively assesses client needs and develops processes and solutions to address issues
• Excellent interpersonal and intercultural communication skills, both written and verbal
B.Pharm, M.Pharm or any life sciences related discipline
Qualification : B.Pharm, M.Pharm
Location : Bengaluru, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Job ID : 61354BR
End Date : 30th November, 2020