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. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Consultant Regulatory Affairs
Job Description:
Essential Skills
- Responsible for the coordination and the preparation and review of documents/packages for regulatory submissionn, CTA/MAA
- Review and evaluate technical and scientific data and reports required for submission
- Develop and execute regulatory strategy for CTA, MAA and maintenance of licences/authorizations according to needs
- Track status and progress of regulatory documentation
- Review of labels
- Monitor applicable regulatory requirements; assure compliance with the company's and external standards
- Compile and prepare responses to regulatory authorities queries
- Maintain regulatory files in a format consistent with requirements
- Establish communication and good working relationships within other functions and the health authorities
- Awareness of regulatory requirements
- Liasoning with DCGI office/customs/Central Drug Labs and other regulatory authorities
- Pre-submission screening for all DCGI submissions.
- Follow-up with external experts for receiving the documents and sending their comments to DCGI
Candidate profile:
Experience
- Minimum of 4 years of experience in clinical research regulatory affairs and exposure to product registrations
Education
- Educated to minimum of Graduation in LifeScience or equivalent experience in Clinical Research Regulatory Affairs
Language
- Excellent English communication skills
Additional Information:
Location: India - Haryana - Gurgaon
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 3rd Feb, 2012
Note: Candidates with 4 years Experience in Clinical Research Regulatory Affairs can directly send their CV to kirloskar.das@parexel.com
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