Regulatory Affairs Manager

5 months ago

Sydney, Australia Guerbet Full time

Guerbet is a human-scale company that aims to become a new global leader in medical imaging.

Pioneer in contrast media with 90 years' experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors.

The company offers a comprehensive range of CT scan, Cath Lab, Magnetic Resonance Imaging (MRI) and Interventional Radiology and Theranostic (IRT) products, along with a range of injectors and related medical devices to improve patients' diagnosis, prognosis and quality of life.

More than 60,000 health professionals rely on Guerbet's contrast agents. Advancing in innovation solutions, the diagnosis of major diseases (cardiovascular diseases, cancers, diseases of the central nervous system) and interventional radiology while reconciling efficacy and cost containment, are at the heart of Guerbet's mission.

Its total workforce is of 2,700 employees. Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

**Common missions for this position**

(Geographical perimeter = Australia and New Zealand)

**Main responsibilities**
- Regulatory Affairs
- Drive pharmaceutical and medical device registrations in accordance with relevant Health authority regulations for Australia and New Zealand and develop the regulatory strategy to obtain product authorisation within target timeframes.
- Solve complicated registration issues.
- Keep informed of corporate regulatory procedures and product changes to ensure product registration is maintained in compliance with local regulations.
- Effectively communicate and collaborate with regional/corporate RA teams and GANZ team to develop Global Regulatory Strategies.
- Assessment of new regulations for medicines and medical devices and provide plans for complying with new requirements as required.
- Provision and maintenance of regulatory information for Guerbet Information systems. Plan and implement policies, procedures, practices, and strategies for participation in applicable industry working groups and standards committee and communicates industry movement and potential regulatory changes internally.
- Establish and review RA priorities as they relate to local and corporate goals and objectives. - Manage multiple, sometimes conflicting priorities.
- Complete tasks as assigned.
- Product label management and support the plan coordination on packing changes

2. Qualified Person Quality Management System
- With support of regional Distribution Quality Team, supervise and oversee the establishment, implementation and management of GXP quality management system.
- To ensure local QMS aligns with global standard operating procedures and instructions, local regulation and law.
- Responsible for overseeing and supervision of PV/QA Specialist in his/her duty concerning GXP quality management system.
- Support and manage the QMS system in accordance with ISO9001 regulations. Subcontractor and vendor management
- Be the quality contact person dealing with subcontractors including TPLs in Australia and New Zealand, of which the services and/or products have impact to GDP, patient safety and/or product quality.
- Support the management and monitoring of subcontractor, vendor and GXP related service provider in close collaboration with global and regional quality department. Health Authorities Referent
- Manage and support Health Authorities inspection or Corporate audit and define action plan to resolve the observations when applicable.
- Be the quality referent for local Health Authorities. GXP operation
- With support of regional Distribution Quality Team, supervise and oversea the GXP operation to ensure GXP requirements are fulfilled.
- Responsible for overseeing and supervision of PV/QA Specialist in his/her duty concerning routine GXP operation.
- Support company development and fulfill planned and ad hoc tasks assigned by senior management.

3. Pharmacovigilance
- When requested, act as either the Locally Responsible Pharmacovigilance Person (LRPP), or Deputy LRPP, for managing overall responsibility of the PV activities in Australia.

4. Compliance Management
- Conducting compliance review of all advertising and promotional materials for medicines and medical devices for GANZ.
- Ensure compliance with current approved prescribing documents for medicines and technical files for medical devices - Ensures compliance with regulatory requirements and industry codes
- Ensures alignment with claims with PBS/PHARMAC restrictions and appropriate disclaimers.

5. People Management
- Supervision and mentoring of direct line reports.

**Educations & Experiences**
- 10+ years RA medicine and medical device regulatory experience i

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