Regulatory Affairs Coordinator - Mexico, Panama & Distributors M/F (28205)

At 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

YOUR ROLE

• Coordinate the preparation and assembly of regulatory submissions for medical devices and pharmaceuticals products to ensure timely completion and filing as required in Mexico and Panama affiliates.

• Support in-country regulatory consultants and/or local distributors through Latin America to ensure filling of regulatory submissions to the respective regulatory bodies.

• Be aware of the regulatory strategy of the company.

• Manage regulatory submissions tracking process in Mexico and Panama, establishing timelines for product maintenance submissions. • Closely supervise regulatory consultants and/or local distributors in Latin America, regarding the regulatory activities relating to Guerbet products (e.g., variations, renewals, notices, withdrawals, new registrations, etc.).

• Coordinate with the local regulatory team the proper submission documents needed during the life cycle of the products in Mexico and Panama (variations, renewals, notifications, withdrawals, promotional materials, and new registrations), as well as internal corrections and import permits, when applicable.

• Interact with local regulatory bodies where needed or through local in-country consultants to discuss project feasibility, strategies to achieve fast-track approvals and assess the impact of change control for the regional marketing authorizations.

• Ensure that all product lifecycle information (approvals, notices, rejections, or any other information with regulatory impact) are provided to Headquarters in a timely manner.

• Represent the Manager/Director in meetings of class entities and/or in meetings with regulatory bodies, as delegated.

• Maintain internal processes in accordance with local and regional legislations, and global procedures.

• Assist the LATAM Regulatory Affairs Manager on regulatory projects for Mexico, Panama and for distributors.

• Provide regulatory support for other corporate areas.

• Analyze, translate, prepare, or adapt the technical documentation in accordance with the legislation in force for the registration, variations, processes, and certifications of good manufacturing practices, according to the reference documents, meeting the established deadlines.

• Monitor and perform review, update, and maintenance of packaging and labeling artworks workflow for Mexico, Panama, and distributors, when applicable, to follow regulatory authorities and headquarter datasheet.

• Perform and supervise the procedures to include the products in the public health system, when feasible.

• Create, modify, put in force or withdrawn SOPs on regulatory affairs matters.

• Develop and conduct training programs regarding regulatory affairs

YOUR BACKGROUND

• Academic background: Bachelor’s degree or equivalent in health sciences, chemical pharmaceutical discipline, or related (Essential) with an active registration in the respective Regional Council.

• Solid knowledge of the legislation for medicines and medical devices in the applicable countries.

• Fluency in English.

• At least 5 years of previous Regulatory experience.

• Experience working with external consultants.

• Adapted to work in matrix reporting environment.

• Self-motivated to work in a multicultural environment

• Knowledge of standard Office software packages (e.g., Word, Excel).

• Availability to travel when needed.

Reason to join US

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 committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com.