Job Description

Job Title: Regulatory Review Advisor - Global Business ServicesCareer Level: CIntroduction to role:Are you ready to make a difference in the world of regulatory compliance? As a Regulatory Review Advisor, you'll play a crucial role in ensuring adherence to vital safety and regulatory reporting obligations. Protecting patients and maintaining our client's reputation with Regulatory Authorities is at the heart of this position. You'll be part of the GBS Central Regulatory Reporting Team, collaborating with local PS organizations and stakeholders to meet both local and global PS requirements. Your expertise will support the activities of the GBS Regulatory Reporting Function and the wider Client PS function, delivering routine Regulatory Review activities independently while resolving moderate scope and complexity issues.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, being audit and inspection ready.
• Support external service providers to meet company and local regulatory PV requirements.
• Complete all required patient safety trainings in adherence to internal processes and external regulations, obtaining 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 authorityxe2x80x99s 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.At AstraZeneca, we are driven by our passion for science and innovation. Our commitment to making a difference is evident as we work towards treating some of the world's most complex diseases. By fusing data and technology with scientific advancements, we aim to achieve groundbreaking breakthroughs. Our inclusive environment encourages collaboration across academia, biotechs, and industry partners. Here, curiosity thrives as we explore new ways to handle diseases. With opportunities for lifelong learning and career development, AstraZeneca is where you can truly make an impact on patients' lives.Ready to take on this exciting challenge? Apply now to join our team!Date Posted 29-Apr-2025Closing Date 12-May-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