Opening for the post of Regulatory Affairs - Assistant Manager @ USV LIMITED - India
Job description
Regulatory support and review for pre-filing and development documentation
Coordination with internal and external stakeholders for regulatory filing related documentation
Review, compilation and authoring of Sterility Assurance and Sterile Process Validation
Review of plant and R&D documentation such as BMR, BPR, Specifications etc
Authoring, Compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier
Post approval filing such as supplement and annual report
Desired Skills and Experience
- Candidate must have atleast 6 years of sterile filing experiecne in US market.
We are a leading health care company with the following areas of focus: Generics, Active Pharmaceutical Ingredients (APIs) and Bio-similars. 67% percent of our business is contributed by the India operations and the rest by export of APIs and Generics.
USV is a 48 year old health care company which began as a joint venture with USV&P Inc a subsidiary of Revlon.
Our product range consists of Generics, Active Pharmaceutical Ingredients and Bio-therapeutics that are manufactured in our modern cGMP compliant manufacturing facilities located in India.
We market our products globally to over 40 countries. In financial year of 2008-09 our sales were Rs. 8,451 million.
Our Indian business contributes to 67% of our sales. In India we are recognized for our leadership in the areas of Diabetes where we are leaders by Rx and Value in the oral segment. In the Cardiovascular segment we are a number 1 by Rx a top 10 company by value. We also have significant presence with leading brands in areas of Gynecology, Dermatology, Gastroenterology and General Practice.
Our international business contributes 33% to our sales. The product portfolio for international markets consists of:
A large portfolio of small molecule APIs. Of the 52 products in our portfolio, 23 APIs are commercially available with others in various stages of development. Our special skills include production and characterization of polymorphs, particle sizing
A portfolio of 34 solid oral finished products that span immediate release, modified release and products with 'complex' characteristics.
A portfolio of 17 injectables and ophthalmic products based on small molecules.
A portfolio of 4 rDNA based Bio-Similars or Follow-on-Biologics.
We see a bright future for USV in the coming years. We provide an environment that values people, promotes learning, nurtures innovation and rewards excellence.
Click here to apply
Job description
Regulatory support and review for pre-filing and development documentation
Coordination with internal and external stakeholders for regulatory filing related documentation
Review, compilation and authoring of Sterility Assurance and Sterile Process Validation
Review of plant and R&D documentation such as BMR, BPR, Specifications etc
Authoring, Compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier
Post approval filing such as supplement and annual report
Desired Skills and Experience
- Candidate must have atleast 6 years of sterile filing experiecne in US market.
We are a leading health care company with the following areas of focus: Generics, Active Pharmaceutical Ingredients (APIs) and Bio-similars. 67% percent of our business is contributed by the India operations and the rest by export of APIs and Generics.
USV is a 48 year old health care company which began as a joint venture with USV&P Inc a subsidiary of Revlon.
Our product range consists of Generics, Active Pharmaceutical Ingredients and Bio-therapeutics that are manufactured in our modern cGMP compliant manufacturing facilities located in India.
We market our products globally to over 40 countries. In financial year of 2008-09 our sales were Rs. 8,451 million.
Our Indian business contributes to 67% of our sales. In India we are recognized for our leadership in the areas of Diabetes where we are leaders by Rx and Value in the oral segment. In the Cardiovascular segment we are a number 1 by Rx a top 10 company by value. We also have significant presence with leading brands in areas of Gynecology, Dermatology, Gastroenterology and General Practice.
Our international business contributes 33% to our sales. The product portfolio for international markets consists of:
A large portfolio of small molecule APIs. Of the 52 products in our portfolio, 23 APIs are commercially available with others in various stages of development. Our special skills include production and characterization of polymorphs, particle sizing
A portfolio of 34 solid oral finished products that span immediate release, modified release and products with 'complex' characteristics.
A portfolio of 17 injectables and ophthalmic products based on small molecules.
A portfolio of 4 rDNA based Bio-Similars or Follow-on-Biologics.
We see a bright future for USV in the coming years. We provide an environment that values people, promotes learning, nurtures innovation and rewards excellence.
Click here to apply
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