Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

Tuesday, September 7, 2010

Executive- International Regulatory Affairs pharmanaukri.info

Summary

Experience: 2 - 5 Years

Location: Bengaluru/Bangalore

Education: UG - B.Sc - Any Specialization

PG - M.Sc - Any Specialization

Industry Type: Pharma/ Biotech/Clinical Research

Role: Regulatory Affairs Mgr

Functional Area: Healthcare, Medical, R&D


Desired Candidate Profile

Description: To assist IRAG in obtaining and maintaining licences in accordance with agreed regulatory strategy for designated therapy areas and products.


Major Responsibilities:

• Input regulatory intelligence and regulatory requirements into relevant systems and databases maintaining data accuracy

• Support the product registration and maintenance of designated TA products in accordance with standards of regulatory compliance


• Assist team with assigned projects where appropriate

• Responsible for distribution of assigned submissions to all relevant marketing companies/distributors


• Responsible for ordering of registration samples, Certificates of Pharmaceutical Product and any other legal documentation as required


• Management of submission life-cycle information in GEL in accordance with standards

Minimum Requirements:

• Relevant experience from elsewhere in Pharmaceutical Industry

• Good commercial and product awareness

• Some regulatory/medical/technical experience

• Some knowledge of submission, compilation, publishing and approval processes, standards, systems and tools.


Skills and Capabilities

Project planning Focus on delivery and results


Communication and influencing skills Problem solving

Flexibility and adaptability IS/IT

Interpersonal and networking skills Cultural awareness

Team working Proactivity

Organisational skills Self awareness

Internal and External Contacts/Customers

International Marketing Companies, Health authorities

Job Description

Description: To assist IRAG in obtaining and maintaining licences in accordance with agreed regulatory strategy for designated therapy areas and products.

Major Responsibilities:

• Input regulatory intelligence and regulatory requirements into relevant systems and databases maintaining data accuracy

• Support the product registration and maintenance of designated TA products in accordance with standards of regulatory compliance

• Assist team with assigned projects where appropriate

• Responsible for distribution of assigned submissions to all relevant marketing companies/distributors

• Responsible for ordering of registration samples, Certificates of Pharmaceutical Product and any other legal documentation as required

• Management of submission life-cycle information in GEL in accordance with standards

Minimum Requirements:

• Relevant experience from elsewhere in Pharmaceutical Industry

• Good commercial and product awareness

• Some regulatory/medical/technical experience

• Some knowledge of submission, compilation, publishing and approval processes, standards, systems and tools.

Skills and Capabilities

Project planning Focus on delivery and results

Communication and influencing skills Problem solving

Flexibility and adaptability IS/IT

Interpersonal and networking skills Cultural awareness

Team working Proactivity

Organisational skills Self awareness

Internal and External Contacts/Customers

International Marketing Companies, Health authorities

Keywords: RA, Regulatory Affairs, Regulatory

Click here for more info and Apply

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