Job Description

Job Title: Regulatory Review Advisor - Global Business ServicesCareer Level - CIntroduction to role:The Regulatory Review Advisor will ensure compliance with critical safety and regulatory reporting obligations, protecting patients and maintaining our client's reputation with Regulatory Authorities. Working as part of the GBS Central Regulatory Reporting Team, the successful candidate will support local PS organizations in achieving compliance with company and regulatory requirements by building relationships and collaborating with internal and external collaborators to ensure local and global PS requirements are met. The role will support activities of the GBS Regulatory Reporting Function as well as the wider Client PS function and work under the guidance of local PS teams and/or more senior experts with the expectation to deliver routine Regulatory Review activities independently, including resolving problems of moderate scope and complexity, conducting activities and interactions consistent with things we value and in compliance with the Code of Conduct, supporting policies and standards relevant to the role.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 Affairs, Client PS Teams) to ensure alignment on regulatory reporting requirements
• 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, via contribution to all safety-related processes and brand activities within countries of remit and being audit and inspection ready.
• Support external service providers to meet the company and local regulatory PV requirements.
• Complete all required patient safety trainings in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate.
• Maintain current and in-depth knowledge of:
• Relevant country regulatory authority regulations
• Global and local procedural and guidance documents
• Conditions, obligations, and other commitments relating to product safety or the safe use of AZ products

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
• Knowledge of health authoritys regulations
• Cross-functional collaborative approach
• Effective and lateral thinking
• Problem-solving
• Vendor management
• Excellent attention to detail
• Excellent written and verbal communication skills

Desirable Skills/Experience:

• Medical knowledge in company Therapeutic Areas
• Successful participation in above-market projects
• Audit & Inspection experience

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Join a team with the backing and investment to win! You'll be working with cutting-edge technology. This marriage between our purposeful work and the use of high-tech platforms is what sets us apart. Lead the way in digital healthcare. From exploring data and AI to working in the cloud on new technologies. Join a team at the forefront. Help shape and define the technologies of the future, with the backing you need from across the business.Ready to make an impact? Apply now!Date Posted 17-Apr-2025Closing Date 26-Apr-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca