JOB DESCRIPTION:
Regulatory Affairs Regional Product Lead, this position is 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 Regional Product Lead, you’ll act as primary contact between the Latin American subsidiaries and the different internal and external suppliers for regional TPM products, with the purpose of providing the necessary technical and legal support to execute and maintain the regulatory processes before the health authorities of the region.
What You’ll Do
Strategic:
- Review of the impact of new regulations for notification to the plants in favor of implementation of changes.
- Manage on boarding meetings with affiliates in Latam to determine the timelines and regulatory requirements required to develop new regulatory projects in the region, such as new registrations, manufacturing site changes and others.
- Support for the elaboration, update, promulgation and/or execution of the procedures, work instructions of the area.
- Ensure that affiliates work and integrate processes with other areas of the company to obtain the planned regulatory results.
- Alert product and project leaders about possible situations that may affect the development of regulatory processes.
- Alert affiliates of eventualities or changes that alter times or criteria of planned regulatory processes.
- Cooperate with global working groups and manufacturing sites for the implementation of post-registration changes and planning of regulatory activities.
Legal:
- Under the supervision of the Coordination of Regulatory Affairs, carry out the review from the regulatory point of view of Confidentiality Agreements - CDAs, Non Binding Term Sheet - NBTS, Due Diligence and Contracts for new and renewals deal prior to signing the documents.
- Under the supervision of the Coordination of Regulatory Affairs, carry out the review of Quality Agreements - QTAs, Pharmacovigilance Agreements - PV prior to signing the documents.
- Manage Good Manufacturing Practices (GPM) certificates, pharmaceutical product certificates (CPP), manufacturing agreements, powers of attorney and letters of authorization for registration purposes, following corporate guidelines and regulatory requirements. Also manage the sending of physical and apostilled documents to affiliates.
Technical:
- Manage with the manufacturing plants the technical and legal documentation for registration purposes, supporting the submission in the Latam affiliates, in addition to responding to the requirements of the health authorities.
- Responsible for managing the dossiers to maintain the annual renewal program.
- Support the life cycle of products, cooperating in the regulatory impact assessment of changes proposed by manufacturing plants, supporting the documentation of implementation actions in the SoltraQs system or the system intended for that purpose.
- Responsible for the process of harmonization, release and notification of productive artworks for the region.
- Management for the sending of samples, standards and others required for registration purposes or for the release of the first batch to the market in the countries in which it applies.
- Maintenance of the regulatory documentation required to apply to tender processes
- Diagnosis of regulatory compliance of the dossiers approved by the health agencies versus the effective information in the plant and definition of the activities necessary to close the findings, generating documentary remediation.
- Alert affiliates of eventualities or changes that alter times or criteria of planned regulatory processes.
- Support in the process of launching products to the market by reviewing and signing the First Lot Quality Review document
- Respond for the handling of confidential information.
Systems:
- Create and ensure the updated maintenance of regulatory monitoring activities in the Global Data Management systems and in the local tools designed for this purpose. (BIFs, SI Report, Reg Activities, others)
- Upload of dossiers in the Global Data Management systems (dossier compilation).
- Opening and monitoring of Change Controls in the SoltraQs system for documentation of post-registration changes until the implementation is carried out.
- Comply with other tasks that are assigned and inherent to this position, such as special global projects.
Required Qualifications
- Bachelor's Degree in Pharmaceutical Chemistry (Licentiate, Graduated).
- 3-5 years of experience in Regulatory Affairs, Latin American Regulation and/or similar position.
- Language skills, Advanced English B2.
- Knowledge in Good Manufacturing Practices.
- User-level computer system management. Microsoft Windows/Office.
Apply now
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
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Guatemala > Guatemala : 5a Ave 5-55 Zona 14
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
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