Regulatory Affairs Specialist
hace 3 días
Guerbet is a global leader in medical imaging, offering a comprehensive portfolio of pharmaceuticals, medical devices, digital solutions, and AI technologies for diagnostic and interventional imaging. With a rich history spanning 95 years, Guerbet has established itself as a pioneer in contrast products and continues to innovate, dedicating 10% of its revenue to Research & Development to improve patient diagnosis, prognosis, and quality of life.
About the RoleThe Regulatory Affairs Coordinator will play a crucial role in coordinating regulatory submissions for medical devices and pharmaceutical products in Mexico and Panama affiliates, ensuring timely completion and filing with regulatory bodies. This position requires close collaboration with in-country regulatory consultants and/or local distributors to ensure compliance with regulations.
Responsibilities:- Support in-country regulatory consultants and/or local distributors in Latin America to ensure filing of regulatory submissions to respective regulatory bodies.
- Maintain awareness of the company's regulatory strategy and ensure alignment with local requirements.
- Manage regulatory submissions tracking process in Mexico and Panama, establishing timelines for product maintenance submissions.
- Supervise regulatory consultants and/or local distributors regarding regulatory activities relating to Guerbet products (e.g., variations, renewals, notices, withdrawals, new registrations, etc.).
- Closely coordinate with the local regulatory team on submission documents needed during the product lifecycle in Mexico and Panama.
- Interact with local regulatory bodies or through local in-country consultants to discuss project feasibility, strategies for fast-track approvals, and assess the impact of change control on regional marketing authorizations.
- Evaluate product lifecycle information (approvals, notices, rejections, or any other information with regulatory impact) and provide it to Headquarters in a timely manner.
- Represent the Manager/Director in meetings of class entities and/or with regulatory bodies, as delegated.
- Maintain internal processes in accordance with local and regional legislations and global procedures.
- Academic background: Bachelor's degree or equivalent in health sciences, chemical pharmaceutical discipline, or related field (Essential) with an active registration in the respective Regional Council.
- Solid knowledge of legislation for medicines and medical devices in applicable countries.
- Fluency in English.
- At least 9 years of previous Regulatory experience in Pharmaceutical companies.
- Experience working with external consultants.
- Adapted to work in a matrix reporting environment.
- Self-motivated to work in a multicultural environment.
- Knowledge of standard Office software packages (e.g., Word, Excel).
$80,000 - $110,000 per year, depending on experience.
BenefitsGuerbet offers continued personal development opportunities, allowing you to grow professionally and contribute to the success of our organization. As a global leader in medical imaging, we value diversity, equity, and inclusion, striving to create a workplace where everyone feels valued and respected. We are committed to equal employment opportunities and welcome applications from candidates of all backgrounds.
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