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Regulatory Review Advisor

3 weeks ago

Bengaluru Karnataka, India AstraZeneca Full time

**Job Title: Regulatory Review Advisor - Global Business Services**:
**Career Level - C**

**Introduction to 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
- 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 authority’s 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.