Abbott Gerente de Asuntos Regulatorios / Regulatory Affairs Manager in Cuidad de Mexico, Mexico
PRIMARY JOB FUNCTION:
This position performs specialized level work assignments coordinating registration activities in Mexico, Central America and Caribbean region, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.
Provide regulatory support for the realization of the files to distributors in charge in Mexico, Central America and Caribbean region. Reviews and evaluates potential changes to the products that could impact the current licenses, also changes in regulations that could impact to the company and therefore products and licenses.
May interface directly with Ministry of Health in Mexico and other regulatory agencies in Central America and Caribbean Region.
Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
Define regulatory strategies to meet to the 4 BUs (CAHF, AV, NM and SH) the launching plan for each period.
Grant the importation of the 4 BUs referenced for Mexico, Central America and Caribbean Region even when there are continuous changes in the licenses.
Provide regulatory strategies to combine rebranding activities, licenses renewals and coming changes in the current licenses for SJM and AV.
Keep communication in timely manner with cross functional areas regarding regulatory changes with impact to the business.
Bachelor degree in Pharmaceutical, Biology, Engineering or related discipline.
Fully bilingual: Spanish and English
Generally, 7+ years of relevant experience
Demonstrated leadership competencies
Excellent interpersonal skills
Responsibility for budget of Registration Process in Mexico, Central America and Caribbean Region.
Responsibility of 3 RA Specialists to provide regulatory support to Mexico, Central America and Caribbean Region.
Responsibility to provide support to 4 BUs: AV, CAHF, NM and SH in Mexico, Central America and Caribbean Region.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com