AddressAt Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
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 in ANZ
- Knowledge of medicine and medical device regulations in ANZ.
- Attention to detail and overall medicine/device application, quality and internal consistency.
- Understanding of pharmaceutical and medical device industry procedures and terminology.
- Sufficient Qualification/ experience in GDP & quality management Skills & Qualifications
- Excellent written and oral communications skills.
- Strong interpersonal and negotiation skills, conflict management, priority setting, strategic agility, managing vision and purpose.
Much more than a Competitive salary,
We offer continued personal development. When you join Guerbet, you :
- Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
- Are joining a company where we value diversity of talents coming from various horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to *******@guerbet.com or you can also call this number +19843443717
