Job Title: Regulatory Review Advisor - Global Business Services
Job Location: Bangalore, India
Company Overview
AstraZeneca is a global, science-led biopharmaceutical company committed to discovering and developing innovative medicines for patients around the world. The company works with leading partners in academia, biotechs, and industry to advance scientific breakthroughs. AstraZeneca fosters an inclusive and collaborative environment, where curiosity drives progress, and people thrive through lifelong learning opportunities.
Role Summary
The Regulatory Review Advisor will play a vital role in ensuring compliance with safety and regulatory reporting obligations. This position involves working with the GBS Central Regulatory Reporting Team to ensure accurate and timely submission of regulatory reports, including Adverse Event Reports and Periodic Safety Update Reports. The role also requires collaboration with safety teams and cross-functional teams to meet local and global pharmacovigilance reporting standards.
Key Responsibilities
Regulatory Reporting Compliance
Ensure timely submission of regulatory reports, such as Adverse Event Reports and Periodic Safety Update Reports.
Interpret and apply global regulatory reporting requirements for health authorities.
Monitor updates to regulatory guidelines and ensure alignment with GBS processes.
Adverse Event and Safety Reporting
Coordinate pharmacovigilance reporting activities ensuring compliance with Good Pharmacovigilance Practices (GVP).
Assist in safety reporting, risk assessments, and ensure submission of Individual Case Safety Reports.
Regulatory Documentation & Submissions
Prepare and submit regulatory documents while ensuring compliance with legal requirements.
Maintain documentation for regulatory audits and inspections.
Work with cross-functional teams (e.g., Quality Assurance, Medical Affairs) to ensure compliance with reporting obligations.
Training and Process Improvement
Provide training and guidance to internal teams on regulatory reporting practices.
Support audits and regulatory inspections by ensuring compliance with internal and external requirements.
General Responsibilities
Contribute to maintaining Good Pharmacovigilance Practices.
Collaborate with external service providers to meet safety and regulatory obligations.
Required Qualifications
Education: Bachelor’s degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field.
Experience: 3+ years of experience in regulatory affairs, pharmacovigilance, or regulatory reporting in the pharmaceutical industry.
Skills:
Strong knowledge of pharmacovigilance and Good Pharmacovigilance Practices (GVP).
Understanding of health authority regulations.
Excellent attention to detail and communication skills.
Collaborative approach and effective problem-solving skills.
Desirable Qualifications
Medical Knowledge: Knowledge of therapeutic areas relevant to AstraZeneca.
Audit Experience: Experience in audits and inspections.
Work Environment
AstraZeneca emphasizes a flexible working environment with in-person work at least three days per week to foster collaboration.
How to Apply
Candidates can apply through the AstraZeneca career portal before the closing date of May 12, 2025.
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