AstraZeneca Regulatory Review Advisor Job For Life Sciences – Apply Now!
Introduction to company:
AstraZeneca is a global biopharmaceutical company dedicated to advancing science to deliver life-changing medicines. Our focus is on innovation and collaboration to improve patients’ lives and combat diseases worldwide.
Job Title: Regulatory Review Advisor – Global Business Services
Location: India – Bangalore
Time Type: Full time
Posted on: Posted Today
End Date: April 27, 2025
Job Requisition ID: R-224684
Accountabilities:
Regulatory Reporting Compliance
Ensure timely and accurate submission of regulatory reports, including Adverse Event Reports, Periodic Safety Update Reports, and other required documentation
Interpret and apply global regulatory reporting requirements including those for health authorities
Monitor updates to regulatory guidelines and ensure internal GBS processes align with evolving reporting standards
Adverse Event and Safety Reporting
Coordinate pharmacovigilance reporting activities, ensuring compliance with Good Pharmacovigilance Practices
Work closely with safety teams to assess, process, and submit Individual Case Safety Reports within required timescales
Assist in detection and risk assessment activities to client safety protocols
Regulatory Documentation & Submissions
Prepare, review, and submit regulatory reports, ensuring completeness, accuracy, and compliance within legal requirements
Maintain documentation for regulatory audits and inspections
Collaborate with cross-functional teams (e.g., Quality Assurance, Medical
Training and Process Improvement
Provide training and guidance to GBS internal teams on regulatory reporting obligations and best practices
Support audits and inspections by regulatory authorities and implement corrective actions as needed
General
Actively contribute to maintaining the core components of Good Pharmacovigilance Practice
Support external service providers to meet the company and local regulatory PV requirements
Maintain current and in-depth knowledge of relevant regulations, procedural documents, and product safety commitments
Essential Skills/Experience:
- Bachelor’s degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field 3 years+ of experience in regulatory affairs, pharmacovigilance or regulatory reporting in the pharmaceutical industry
- Pharmacovigilance knowledge excellence
- Good Pharmacovigilance Practice
- Effective problem-solving skills
- Excellent written and verbal communication
Desirable Skills/Experience:
- Medical knowledge in company Therapeutic Areas
- Audit & Inspection experience
- Cross-functional collaborative approach
About the Company Culture:
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. Join a team with the backing and investment to win! Our unique and ambitious world encourages individual flexibility while respecting the expectation of office collaboration. Embrace digital healthcare and shape the technologies of the future.
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