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Thursday, March 1, 2012

Manager - Regulatory Affairs by Titan Laboratories Pvt. Ltd in Mumbai


Job DescriptionSend me Jobs like this
Candiadate should have complete knowledge of

 
1. Hands on experience in Clinical Trial Applications (CTA), Clinical study report preparation.

2. Preparation of Replies to Questions and Compliance reports to regulatory authorities viz. EMEA, MHRA, FDA.
3. Excellent Leadership qualities with strong analytical, problem solving and interpersonal skills
4. Solid Project Management experience coupled with good exposure to R&D and entrepreneurial abilities to set up companies regulatory affairs department
5. In depth knowledge in Preparation and filing CTD dossier in EU & UKMHRA

 

Salary:
INR 5,00,000 - 7,00,000 P.A
Industry:
Pharma, Biotechnology, Clinical Research
Functional Area:
Healthcare, Medical, R&D
Role Category:
Drug Regulatory Affairs/Documentation
Role:
Regulatory Affairs Manager
Keyskills:
Knowledge of USFDA & MHRA audit
Desired Candidate Profile
Education:
(UG - B.Pharma - Pharmacy) AND (PG - M.Pharma - Pharmacy)
Candiadate should have complete knowledge of Hands on experience in Clinical Trial Applications (CTA), Clinical study report preparation. Preparation of Replies to Questions and Compliance reports to regulatory authorities viz. EMEA, MHRA, FDA. Excellent Leadership qualities with strong analytical, problem solving and interpersonal skills Solid Project Management experience coupled with good exposure to R&D and entrepreneurial abilities to set up companies regulatory affairs department In depth knowledge in Preparation and filing CTD dossier in EU & UKMHRA
Company Profile
Titan Laboratories Pvt. Ltd
http://www.titan-lab.com
Titan is a specialty Pharmaceutical company engaged in developing and manufacturing Sustained and Modified Release Pellets using Innovative Drug Delivery Technologies Utilizing some of best and latest processing machineries like Fluid Bed Processor with inherent built in rotary unit coupled with Top And Bottom Spray arrangement. This is essential to achieve uniformity and efficiency in layering and/ coating process which in turn will ensure in consistent release characteristics. Facility of Extruder & spheronizer is also available for effective pelletizing selectivity depending.
Contact Details
Address:
102, Titan House, 60 Feet Road, Opp. Bank of Maharashtra, Ghatkopar(E) MUMBAI,Maharashtra,India 400077
Email Address:
Telephone:
91-22-02267857000

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