Regulatory Affairs Executive Require at Astra Zeneca - M.Pharm, M.Sc, B.Pharm
AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.
Post : Executive - Regulatory Affairs
Job Description
You are responsible to gain rapid and high quality approvals for assigned Global Clinical Trial /Phase IV/PMS for NDA and Marketed products, Regulatory Acceleration process Plan to gain rapid and SEC preparation, 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, you would look after follow up of reports, Licence Life cycle management.
Key Duties and Accountabilities
• Ensure that all the licensing for assigned Global Clinical Trial /Phase IV/PMS for NDA and Marketed products,
• 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
• Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement
• Project manage changes in product licenses and coordinate with other changes, planned and in progress
• Communicate changes to licenses status promptly
• Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy
• Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time
• Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
• Challenge status quo for continuous improvement.
• Help build an open and trusting atmosphere.
• Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals / permissions
• Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes
• Develop excellent relationships and partnerships with Regulatory Authorities
• Monitor and analyse the global pipelines of competing pharmaceutical companies
• Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward
Candidate Profile
• Education - B.Pharma / M.Pharma / M.Sc.
• 2-4 years’ experience in Regulatory function
• knowledge of dossier compilation.
• Conversant with Indian regulations related to new drugs and clinical trials.
• Excellent Communication Skills
• Good Planning and Organisational Skills
• Excellent Scientific knowledge
• Ability to develop Strategic Partnerships
• Develop AZ Values Consistently
• Exposure/ Experience in new drug Approval/GCT experience
• Knowledge of the latest technical and regulatory developments
Additional Information
Qualification : B.Pharma / M.Pharma / M.Sc
Location : Bangalore
Experience : 2-4 years
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May, 2021
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