AstraZeneca Pharma Regulatory Affairs Job – Apply Online
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Job Title: Executive – Regulatory Affairs
Location: India – Bangalore
Eligibility Criteria:Â
- 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
Desirable for the role
- Exposure/ Experience in new drug Approval/GCT experience
- Knowledge of the latest technical and regulatory developments
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, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy
- Develop a 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 analyze the global pipelines of competing pharmaceutical companies
- Provide scenario with options and a risk-benefit analysis for AstraZeneca going forward
What you’ll do
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 a high standard of regulatory compliance, in order to achieve the company’s business objectives. Developing India-specific Artwork, Support to Regulatory dossier preparation and Submissions like New drug application, Site registration, and Import license. Managing Registration sample right from dispatch of samples till the report. As part of the New drug application, ADC sample testing. Also, you would look after a follow-up of reports, Licence Life cycle management.
BUSINESS AREA
REGULATORY AFFAIRS
Be part of redefining our future by thinking and acting differently. Be part of delivering our vision to be the leader in Cardiovascular, Renal, Metabolism, Respiratory and Immunology by 2025. We need to build on our heritage and think and act differently to evolve with the healthcare landscape. From becoming a digitally-enabled enterprise to accelerating launches. It means we are forward-looking, challenge the status quo, reflect on insights, spot opportunities and act on smart risks.
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