Regulatory Affairs Coordinator

Job Description

This position is responsible for coordinating the product registration process to guarantee the approval to market and distribute new products, permissions to market and/or to import products into the various markets under our responsibility. Also responsible for ensuring the appropriate filing/documentation related to product changes.

Internal Stakeholders: Business Units, Functional Support Areas.

External Stakeholders: Health Professionals, Business customers, Government agencies

Major Activities and Responsibilities

Regulatory:

• Support both, local and International strategic initiatives, to improve local productivity and reduce cycle times primarily for the Registrations, renewals and Post Approval Changes processes.
• Promote compliance in alignment with our policies, local and international regulations regarding Drug products Marketing Authorizations and Good Manufacturing Practices.
• Provide continuous support and feedback to local stakeholders regarding status and/or issues.
• Plan and perform regulatory processes including preparation of documents for New Registrations, Renewals and Post Approval Changes processes submission, 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. 
• Coordinate and assures a timely review, development, and approval of the artworks for packaging materials for all products.
• Support to respective departments with Regulatory Documents for Tender Bids.
• Support other regulatory processes, as needed.
• Provide support to the Regulatory Affairs Team, as needed.

           

Compliance:

• Maintain product license in compliance with market supply, and local authority expectations.  Ensure alignment with all applicable change control documents.
• Demonstrate knowledge of, and ensure compliance to, all relevant Regulatory legislation and internal procedures.                                                              
• Maintain appropriate archive (electronic documentation or paper) to ensure that work is traceable and complies with all appropriate regulations.     
• Set quality standards, by participating in the development of appropriate Standard Operating Procedures and Work Instructions for affiliate activities such as submissions, license maintenance, agency interface, labeling, promotional review, quality actions, among others, per policies and applicable local 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 databases.                               

Project Management, Communication:

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

Requirements:

Education & Experience:

• Bachelor’s Degree ("Licenciatura") in Pharmacist or related sciences
• Three (3) or more years of experience in Regulatory Affairs (preferred), Pharmacovigilance, or Quality Assurance. Experience in Pharmaceutical Industry, preferred.
• Knowledge on International Council Harmonization, Good Manufacturing Practices, and local legal regulations of the Central America & Caribbean countries.
• Proficiency in local (Spanish) and English language, in oral and written.
• Proficient in Microsoft Office software
• Willing to travel up to 10% of the time

Skills:

• Effective communication skills
• Effective time management skills
• Execution Excellence
• Networking & Partnership

Required Skills:

Cross-Functional Teamwork, Detail-Oriented, GMP Compliance, Product Registrations, Regulatory Affairs Compliance, 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:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/19/2026

*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.