PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
Post : Regulatory Affairs Specialist
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Job Description
• Assist in the preparation of regulatory affairs documentation
• Prepare regulatory submissions, under guidance
• Review regulatory submissions, under guidance
• Liaise with internal and external clients in the tracking and status update of project plans
• Provide project specific GRA services and co-ordination of these projects
• Liaise with PPD globally to support global projects
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
• Assist with project budgeting/forecasting
• Assist in business development and pricing of projects for GRA in the company
• Other duties as required
Candidate Profile
• Bachelor or higher graduate degree in science-related field
•Substitution of equivalent relevant experience for degree is allowed
• Valid drivers license
• Valid Passport
• Suitable experience working in the pharmaceutical/CRO industry is preferred
Skills and Knowledge:
• English language as well as local language where applicable
• Attention to detail and quality of documentation
• Good interpersonal skills
• Familiar with computers and their applications, e.g. Word, Excel, PowerPoint
• Effective oral and written communication skills
• Basic organizational and planning skills
• Good negotiation skills
• Ability to work on own - under direction
• Proven ability to work effectively in a team environment
• Basic knowledge of global / regional / national country requirements / Regulatory
• Affairs Procedures for Clinical Trial Authorization
• Mental skills required in areas of: Numeracy, Language, Analytical, Investigative,
• Verbal & written communication, Customer contact, Attention to detail, Multiple
• project handling, Reading and interpretation of data
Additional Information:
Qualification : Bachelor’s degree
Location : Gurgaon
Industry Type: Pharma
Functional Area: Quality
Job ID: 146960
Last Date: 21st July, 2018
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