Categories: Pharmaceutical, Regulatory Affairs, Compliance

Job Description

We invite you to join our Company!

This position is responsible for collecting and preparing documentation used by regulatory agencies in Central America & Caribbean countries, in connection with variations involving products. Also assisting in registrations processes, as far as assembling, and distributing documentation to the regulatory agencies. Maintenance of our Regulatory database updated. Also, collaborates internally, with Business Units, Functional Support Areas, and externally, with Health Professionals, Business customers, and Government agencies

Major Activities and Responsibilities

Regulatory:

• Support strategic initiatives to improve local productivity and reduce cycle times primarily for the Registrations, renewals, and PACs processes.
• Perform a regulatory process including preparation of documents for New Registrations, Renewals and PACs submission, besides follow up before the Agency and notification of approval letters.
• Ensure that ORION database and other digital strategies are duly updated with the necessary and/or mandatory records information within the country responsibility, in alignment with the pharmaceutical information for each product. 
• Assure the Artworks for packaging materials are aligned with the finished product.
• Support Tenders Regulatory Documents (Good Manufacturing Practices certificates, Bioequivalence letters and others)
• Support the other regulatory processes as necessary.

           

Compliance:

• Maintain product license in compliance with market supply, and local authority expectations.  Ensure alignment with all applicable change control documents.           
• Appropriate monitoring with the Third Parties/Distributor to ensure the submissions in time of the product’s regulatory processes.
• Maintain appropriate archive (electronic documentation or paper) to ensure that work is traceable and complies with all appropriate regulations.                                
• Ensure prescribing information, labels and other packaging components are in alignment with regulations and core safety information.
• Renewal filing plan / Renewal submitted (measured monthly).     
• Timely Submission / Approval of variation / Request for change.
• Maintain compliance with labeling database, besides all current our databases.

Project Management, Communication:

• As determined, represent Regulatory on cross functional initiatives.
• Work on continuing improvements and simplification.
• Full utilization of Regulatory communication processes.                              

Requirements (Education and Experience):

• Bachelor’s Degree ("Licenciatura") in Pharmacist or related sciences
• Minimum of one (1) year of experience in Regulatory Affairs at a Pharmaceutical Industry is a plus
• Knowledge on local legal regulations of the Central America & Caribbean countries
• Proficient in MS Office software
• Proficiency in Spanish and English, in oral and written
• Willing to travel up to 10% of the time

Skills:

• Networking and Partnership
• Communication
• Organization & Planning
• Time Management

Required Skills:

Cross-Functional Teamwork, Detail-Oriented, Documentations, Pharmaceutical Regulatory Affairs, Regulatory Documents

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

02/1/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.