Coordinador de Asuntos Regulatorios

Regulatory Affairs Coordinator, this position is for the Established Products Division (Pharmaceutical), based in Guatemala City, Guatemala.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• Sales Incentive Plan

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Guatemala City, Guatemala location in the Established Products Division. We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. 

As the Regulatory Affairs Coordinator will be responsible to coordinate and ensure the approval of health records and any regulatory authorization required to implement the marketing and commercialization activities of pharmaceutical products that correspond to the Established Pharmaceutical Division (EPD) for Central America and the Caribbean, in compliance with local regulations, policies and Abbott procedures.

What You’ll Do

• Coordinate activities related to the launch of products (Entry and approval of new registrations, production gear, reconditioning, state control) ensuring compliance with the regulatory requirements of the health authorities to guarantee the timely and proper marketing of the products. the Company according to interest confirmed by Commercial.

• Coordinate the support provided by the Regulatory Affairs team to the commercial team related to information and procedures required to participate in tenders in Central America and the Caribbean Islands.

• Coordinate activities related to the process of renewal of health records (Entry, approval, safety stock) in order to guarantee the supply of products according to interest confirmed by Commercial.

• Coordinate with the applicable areas (Medical, Commercial, Logistics, Supply, Marketing, Quality, among others) the review and approval of the regulatory strategies of the different procedures or communications that are presented to the Health Authorities.

• Coordinate activities related to post-registration changes (entry, approval and implementation). Sign product import invoices based on Regency.

• Comply with corporate policies and procedures, as well as procedures internal and of each Ministry of Health.

• Develop and/or update the Department's standard operating procedures.

• Participate in continuous training processes to develop and implement new ideas and initiatives that improve the organization's performance.

• Provide support to processes related to Regulatory Excellence and provide feedback on the local regulatory environment.

• Transmit knowledge of Regulatory Affairs to pharmacy students in professional practice.

• Update the regulatory systems used by the company.

Required Qualifications

• Bachelor's degree with a Professional Doctorate. Area of specialization: Pharmacy, Chemistry, or similar.

• 2-3 years in related positions.

• English as second language: B2 (Intermediate/High): able to analyze and understand the main ideas of complex texts that cover concrete and abstract topics. You must interact with native speakers with a considerable degree of fluency and naturalness. Produce clear and detailed texts on various topics, as well as defend a point of view or opinion according to the points for and against it.

• Digital skills, Intermediate use of tools such as Outlook, Microsoft Office (Word, Excel, Power Point)

• Experience and skills in managing multiple priorities, Transparency, Industry knowledge, Collaboration.

• Knowledge in detail the regulations on local and global regulatory affairs, stay updated with respect to legal and technical changes that affect the company.

• As an essential legal requirement is to be incorporated into the respective Professional Association.

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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.