Novo Nordisk India Pvt.Ltd

http://www.novonordisk.com

Designation	Experience	Location	Compensation	Education
Executive Regulatory and Quality	0 - 1 Years	Bengaluru/Bangalore	Rupees 2,00,000 – 3,00,000	UG - B.Pharma – Pharmacy PG - M.Pharma – Pharmacy

Industry Type: Pharma/ Biotech/Clinical Research

Functional Area: Healthcare, Medical, R&D

Posted Date: 06 Oct 2008

Job Description :-

Regulatory Affairs :

• Assist the Manager Regulatory Affairs in compiling documentation for submission of applications to regulatory authorities for permission to conduct clinical trials and import drug trials for India.

• Assist the Manager Regulatory Affairs in ensuring that all regulatory guidelines specified by NN A/s and local regulatory authorities are complied with.

• Provide up to date information regarding the stage of the regulatory process â both HQ and locally â update RIMS .

• Follows up on the re-registration process and eliminate and drawbacks which might threaten product availability.

• Assist the Manager Regulatory Affairs for compliance with labelling of products as per local regulatory requirements for India.

• Compile updates for submission to health authorities as and when required .

Local Quality Responsible :

1. Documentation system .

• Administrator of QBIQ .

• Drafting of local quality procedures .

• Co-ordinate reviews and comments on procedure drafts .

• Maintenance and distribution of procedures.

• Maintenance of master list and QBIQ sub-lists .

1. Customer complaints, non-conformities and change control .

• Reporting Customer complaints to CCC/IPS .

• Follow-up on non-conformities and change control .

1. Product release .

• Release of NNA/S and TPL products â India .

• TMD maintenance .

• Reporting of temperature deviations .

Desired Candidate Profile :-Candidates having a Master’s degree in MPharm with minimum 0-1 year of experience in the area of Regulatory and Quality.

Company Profile :-Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. Headquartered in Denmark, Novo Nordisk employs more than 26000 employees in 79 countries, and markets its products in 180 countries .

Executive Name: Krishnanada Nayak

Address: Novo Nordisk India PvtLtd

Plot No.32, 47 – 50,

EPIP Area, Whitefield,

Bangalore,Karnataka,INDIA 560066

Email Address: krin@novonordisk.com

Telephone: 080-40303200

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