PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
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 3.5+ years of experience in Indian Clincial Trials Regulatory Affairs is must.
- Experience in Compiling CTA & Marketing dossiers
- Experience in Interacting with DCGI
- Exposure to product registrations
Education
- Educated to minimum of Graduation in LifeScience or equivalent experience in Clinical Research Regulatory Affairs
Additional Information:
Location: India - Haryana - Gurgaon
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 31st March, 2012
Note: Candidates with Experience in Indian Clinical Trials Regulations, Product Registrations, Experience in Interaction with DCGI, can directly send their Cv to kirloskar.das@parexel.com
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