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
Tuesday, September 7, 2010
Executive- International Regulatory Affairs pharmanaukri.info
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