Post : Executive- Regulatory Affairs
Job Description
Position Purpose:
For assigned products: gain rapid and high quality approvals and ensure high standard of regulatory compliance, in order to achieve the company’s business objectives. Developing India specific Artwork, Support to Regulatory dossier preparation and Submission like New drug application, Site registration and Import licence. Managing Registration sample right from dispatch of samples till the report. As part of New drug application, ADC sample testing. Also follow up for reports, Licence Life cycle management. Coordinating with Clinical Trail team and Global team for GCT application.
Position Purpose:
For assigned products: gain rapid and high quality approvals and ensure high standard of regulatory compliance, in order to achieve the company’s business objectives. Developing India specific Artwork, Support to Regulatory dossier preparation and Submission like New drug application, Site registration and Import licence. Managing Registration sample right from dispatch of samples till the report. As part of New drug application, ADC sample testing. Also follow up for reports, Licence Life cycle management. Coordinating with Clinical Trail team and Global team for GCT application.
Key Result Areas:
• Adherence to AZ and industry codes of conduct, ethics and good regulatory practices
• Ensure that all licensing for assigned products is complete in accordance with relevant norms
• Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch
• Provide Leadership and direction within project teams
• Assist in Issue Management
• Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio
• Competitive Intelligence and analysis
• Adherence to AZ and industry codes of conduct, ethics and good regulatory practices
• Ensure that all licensing for assigned products is complete in accordance with relevant norms
• Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch
• Provide Leadership and direction within project teams
• Assist in Issue Management
• Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio
• Competitive Intelligence and analysis
Candidate Profile
• Qualification- Master’s in science/Master’s in Pharmacy preferred.
• Proficient in oral and written communication (English).
• 2-4 years’ experience in Regulatory function, knowledge of dossier compilation
• S/He should be conversant with Indian regulations related to new drugs and clinical trials.
• Qualification- Master’s in science/Master’s in Pharmacy preferred.
• Proficient in oral and written communication (English).
• 2-4 years’ experience in Regulatory function, knowledge of dossier compilation
• S/He should be conversant with Indian regulations related to new drugs and clinical trials.
Additional Information
Qualification : M.Sc, M.Pharm
Experience : 2-4 years
Location : Bangalore
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 30th January, 2019
Qualification : M.Sc, M.Pharm
Experience : 2-4 years
Location : Bangalore
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 30th January, 2019
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