Job Title: Regulatory Review Advisor - Global Business Services
Location: India - Bangalore
Career Level: C
Introduction to Role: The Regulatory Review Advisor ensures compliance with critical safety and regulatory reporting obligations, protecting patients and maintaining the company’s reputation with Regulatory Authorities. As part of the GBS Central Regulatory Reporting Team, the Advisor supports local PS organizations by collaborating with internal and external stakeholders, ensuring alignment with global and local regulatory requirements. The role involves delivering routine Regulatory Review activities independently while adhering to the organization's Code of Conduct and compliance standards.
Accountabilities:
Regulatory Reporting Compliance:
Ensure timely and accurate submission of regulatory reports including Adverse Event Reports, Periodic Safety Update Reports, and other documentation.
Interpret and apply global regulatory reporting requirements for health authorities.
Monitor updates to regulatory guidelines and align internal processes accordingly.
Adverse Event and Safety Reporting:
Coordinate pharmacovigilance reporting activities in compliance with Good Pharmacovigilance Practices.
Collaborate with safety teams to process and submit Individual Case Safety Reports within required timelines.
Assist in detection and risk assessment activities following client safety protocols.
Regulatory Documentation & Submissions:
Prepare, review, and submit regulatory reports ensuring accuracy and legal compliance.
Maintain regulatory documentation to support audits and inspections.
Collaborate with cross-functional teams to ensure alignment on regulatory reporting requirements.
Training and Process Improvement:
Provide training and guidance to internal teams on regulatory reporting obligations.
Support audits and inspections by regulatory authorities, implementing corrective actions as needed.
General:
Actively contribute to maintaining core components of Good Pharmacovigilance Practice.
Support external service providers in meeting local regulatory PV requirements.
Complete all mandatory patient safety training and maintain access to relevant internal systems.
Stay updated on relevant regulatory authority regulations, global and local procedural documents, and commitments related to product safety.
Essential Skills/Experience:
Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field.
3+ years of experience in regulatory affairs, pharmacovigilance, or regulatory reporting in the pharmaceutical industry.
Strong knowledge of Pharmacovigilance principles and Good Pharmacovigilance Practices.
Cross-functional collaboration abilities.
Effective problem-solving and lateral thinking skills.
Vendor management experience.
High attention to detail.
Excellent written and verbal communication skills.
Desirable Skills/Experience:
Medical knowledge within company Therapeutic Areas.
Experience participating in above-market projects.
Audit and Inspection experience.
Work Model:
Minimum three days per week in-office with flexibility based on individual needs.
About AstraZeneca: AstraZeneca embraces diversity and equality of opportunity. The organization is committed to building an inclusive and diverse team representing all backgrounds, perspectives, and skills. AstraZeneca welcomes applications from all qualified candidates, complying with applicable laws regarding non-discrimination in employment, recruitment, and eligibility verification.
Ready to make an impact? Apply now!
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Siliguri |Illinois :
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