Regulatory Specialist in GlaxoSmithKline
By: Pharma Jobs |
Views: 4613 |
Date: 03-Sep-2012
Established in the year 1924 in India GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 3500 people. Globally, we are a £ 28.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders with a turnover of Rs. 2572 crore and a share of 4.3%*. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a rea
Job as Regulatory Specialist in Glaxo smith Kline
Established in the year 1924 in India GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 3500 people. Globally, we are a £ 28.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders with a turnover of Rs. 2572 crore and a share of 4.3%*. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.Post: Regulatory Specialist
Job Responsibilities:
RESPONSIBILITIES:
* Ability to plan ahead in a highly flexible and evolving environment
* Build and maintain strong and effective relationships with GSK functions (technical groups, country regulatory groups and regulatory network) and third party suppliers
* Co-ordinate and provide support for preparation and dispatch of quality regulatory documents/dossiers (e-)CTD format in agreed timeframes (e.g. regulatory responses, line extensions).
* Develop and communicate submission plans for branded generics (including individual country plans)
* Ensure alignment between area/region and country strategies for regulatory submissions
* Planning, management and implementation of technical variations, label changes and renewals/re-registrations for branded generics
* Provide proposals for resolution of issues, as appropriate
* Proactively pursue process improvement and sharing of best practices
* Proactively contribute towards the development of positions on particular issues on branded generic registrations (may be single or multi-country, product-related or product non-specific)
* Use regulatory knowledge to provide sound regulatory information (e.g. responses to country queries) to other regulatory and technical groups
* Work in line with Company Processes
Candidate Profile:
- Candidate must possess at least a Bachelor of Pharmacy in Pharmacy/Pharmacology or equivalent.
- Required skill(s): Communication Skillls, scientific knowledge.
- At least 3 year(s) of working experience in the related field is required for this position.
- Preferably Junior Executives specializing in Biotechnology or equivalent. Job role in Researcher/Scientist or equivalent.
- 1 Full-Time position(s) available.
Additional Information:
Experience: 3 Years Minimum
Location: Mumbai
Education: B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 24th Sep, 2012
Job ID: 1396011
Click Here to Apply
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