Concept is an integrated healthcare group with a turnover of Rs.125 crores and WHO GMP approved and ISO certified plants in India and Nepal. As a part of corporate strategy we plan to double the turnover within the next two years.
Post: Manager - Regulatory Affairs
Job Description:
Responsible for coordination & timely preparation of regulatory submission
Complete filling of forms & requests applicable to regulatory agencies
Preparation of response to the regulatory queries & deficiencies
Preparation & review of technical documents such as Master production & control documents, analytical method validation protocol & report, Process validation protocol & report, Finished product specification complying with regulatory norms, stability protocol & report
To provide regulatory input in the various functions
Preparation of regulatory audits & inspection
To develop & update regulatory knowledge of European & US regulations
Candidate Profile:
8 to 10 years in the preparation of regulatory submission and regulatory inspection for getting ROW , US & EU marketing authorization. And should have extensive experience in regulatory field.
Additional Information:
Experience: 8-10 Years
Location: Aurangabad
Education: Any
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 25th Feb., 2012
Apply/Send resume at, jobs@conceptpharma.com
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