Regulatory Reporting Manager - Global Business Services

AstraZeneca GmbH; Mississauga; On-site; CAD 90,000 - 130,000; Full time

Job summary

A leading pharmaceutical company seeks a Regulatory Reporting Manager to ensure compliance with safety and regulatory reporting obligations. This role involves coordinating pharmacovigilance activities, leading a team, and ensuring regulatory documentation aligns with standards. Candidates should possess a degree in life sciences and extensive experience in regulatory affairs. The position emphasizes a balance of in-person collaboration and individual flexibility, with a commitment to impacting patients' lives positively through innovative solutions.

Qualifications

• 5+ years of experience in regulatory affairs or pharmacovigilance in the pharmaceutical industry.
• Audit & Inspection experience in a regulatory context.
• Knowledge of health authority’s regulations.

Responsibilities

• Ensure timely submission of regulatory reports including Adverse Event Reports.
• Prepare and maintain documentation for regulatory audits.
• Coordinate pharmacovigilance reporting activities.

Skills

Good Pharmacovigilance Practice

Problem-solving

Attention to detail

Effective communication

Cross-functional collaboration

Education

Bachelor’s degree in Pharmacy, Life Sciences, or Regulatory Affairs

Advanced degree in Regulatory Affairs

Job description

Job Title: Regulatory Reporting Manager

Career level - D

Introduction to role:

Are you ready to make a significant impact in the pharmaceutical industry? As a Regulatory Reporting Manager, you'll play a crucial role in ensuring compliance with vital safety and regulatory reporting obligations. Your work will protect patients and uphold our client's reputation with Regulatory Authorities. Leading the GBS Regulatory Reporting Team, you'll collaborate with internal and external collaborators to meet local and global PS requirements. This role demands independence in delivering routine activities, resolving moderate problems, and maintaining adherence to things we value and the Code of Conduct.

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 local and global regulatory reporting requirements consistently and to quality.
• 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 standard methodologies.
• Develop and improve GBS internal Standard Operating Procedures related to Regulatory Reporting.
• Support audits and inspections by regulatory authorities and implement corrective actions as needed.

General

• Support, guide, and develop the Regulatory Reporting Advisors in line with the client and GBS’ vision and goals for Patient Safety.
• Recruit and train team members where applicable, conduct regular performance reviews, and provide feedback.
• 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 the 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 guidance documents, conditions, obligations, and other commitments.

Essential Skills/Experience:

• Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field
• 5 years + of experience in regulatory affairs, pharmacovigilance or regulatory reporting in the pharmaceutical industry
• Good Pharmacovigilance Practice
• Audit & Inspection experience
• Knowledge of health authority’s regulations
• Cross-functional collaborative approach
• Effective and lateral thinking
• Problem-solving
• Excellent attention to detail
• Excellent written and verbal communication skills

Desirable Skills/Experience:

• Advanced degree (e.g., Master's or certification in Regulatory Affairs)
• Influencing and Conflict Resolution skills
• Medical knowledge in company Therapeutic Areas
• Project management
• Successful participation in above-market projects

When we put unexpected teams in the same room, we ignite 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, your work has a direct impact on patients' lives. We empower our business to perform at its peak by combining brand new science with leading digital technology platforms. Our dynamic environment offers countless opportunities for learning and growth. With a spirit of innovation and experimentation, we tackle challenges that have never been addressed before. Join us as we disrupt an industry and transform healthcare through data, analytics, AI, machine learning, and more.

Ready to take the next step? Apply now to be part of our journey!