SENIOR REGULATORY AFFAIRS OFFICER AT VASAI Thursday, 7 April 2016 No Comment

Job Summary

Locations:

Thane

Experience:

0 – 5 years

Keywords / Skills :

Regulatory Compliance, CTD dossiers, Medical Writing, technical writing, FDA matters, DCGI

Education:

B.Pharm, B.Sc, M.Pharm, M.Sc, PG Diploma

Stream:

• Pharmacy
• Bio-Chemistry/Bio-Technology
• Chemistry
• Microbiology
• Pharmacy
• Bio-Chemistry/Bio-Technology
• Chemistry
• Microbiology

Function:

Pharmaceutical/ Biotechnology

Role:

• Regulatory Affairs Executive
• Data Management/ Statistics
• Documentation/ Medical Writing

Industry:

Pharmaceutical

Salary:

1.80 – 4.00 lacs

Summary:

We are looking for young dynamic individuals for carrying out regulatory work at a reputed pharmaceutical firm in business since 32 years. The responsibilities would include liasening with state FDA and to compile technical dossiers and briefs.

Posted On:

5th Apr 2016

The responsibilities are as under

1. To carry of liasening activiies with the state and centrel FDA

2. To prepare technical dossiers according to CTD and eCTD formats along with country specific requirements

3. To help prepare validation and qualification reports. To summerise and present clinical data.

4. To be the lead person for handling the firms regulatory activities

5. To co-ordinate with external agencies and wherever possible do medical writing and literature survey for products.

:

Regulatory ComplianceCTD dossiersMedical Writingtechnical writingFDA mattersDCGI

Nem laboratories or ‘Nemlabs’ is a Pharmaceutical company with a diverse range of operations. From Pharmaceutical Formulations, material supplies to Bulk Drugs and Turn key projects our product lines are vast and comprehensive. Our motto is to deliver all we do with the " health first " principle in mind.

Ours is a history of serving the Pharmaceutical industry from the past 5 decades, from our humble beginnings back in the 1950’s to our current day operations our commitment to quality has remained unchanged. As a testament; our formulations division has more than 300 products and has completed 25 years of successful service, Our Materials business caters to 12 countries and has completed 20 years of operations and we have successfully installed 12 Pharmaceutical projects worldwide.

Our aim is to further our horizons and deliver quality in all our endeavors, to bring cost-effective solutions to the masses whilst holding true to our ethos.

We deliver Quality, We deliver Health, We are Nemlabs and we welcome you to our family

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Nem laboratories or ‘Nemlabs’ is a Pharmaceutical company with a diverse range of operations. From Pharmaceutical Formulations, material supplies to Bulk Drugs and Turn key projects our product lines are vast and comprehensive. Our motto is to deliver all we do with the " health first " principle in mind.

Ours is a history of serving the Pharmaceutical industry from the past 5 decades, from our humble beginnings back in the 1950’s to our current day operations our commitment to quality has remained unchanged. As a testament; our formulations division has more than 300 products and has completed 25 years of successful service, Our Materials business caters to 12 countries and has completed 20 years of operations and we have successfully installed 12 Pharmaceutical projects worldwide.

Our aim is to further our horizons and deliver quality in all our endeavors, to bring cost-effective solutions to the masses whilst holding true to our ethos.

We deliver Quality, We deliver Health, We are Nemlabs and we welcome you to our family

Follow

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SENIOR REGULATORY AFFAIRS OFFICER AT VASAI

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Tags: Biotechnology / medicine / Pharmaceutical / pharmacy