Farmacéutico de AR: Regulación Global y Cumplimiento

Placements24; Aguascalientes; On-site; MXN 480,000 - 720,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Professional development

Conferences

Job summary

Placements24 is seeking a detail-oriented Farmacéutico de Asuntos Regulatorios in Aguascalientes to lead regulatory submissions, maintain compliance, and liaise with COFEPRIS and other health authorities. You will prepare dossiers, monitor changes, and guide cross-functional teams through the product lifecycle.

The ideal candidate has a pharmacy degree, 3–5 years in regulatory affairs, strong Spanish and English, and proficiency with regulatory information systems.

Qualifications

• Bachelor's degree in Pharmacy or related scientific field.
• 3–5 years of experience in pharmaceutical regulatory affairs.
• Proficiency with COFEPRIS and major international markets.

Responsibilities

• Prepare, review, and submit regulatory dossiers for drug applications and variations.
• Liaise with regulatory agencies (COFEPRIS, FDA, EMA) to facilitate reviews.
• Ensure compliance with national and international regulations and guidelines.
• Manage post-approval regulatory activities: amendments, renewals, annual reports.
• Monitor regulatory changes and assess impact on products and strategies.
• Collaborate with R&D, QA, Manufacturing, and Marketing for submissions.

Skills

Regulatory affairs

COFEPRIS knowledge

English proficiency

Spanish proficiency

Dossier submission

Education

Bachelor's in Pharmacy or related field

Master's in regulatory affairs (nice to have)

Tools

RIMS software

Microsoft Office

Job description

Placements24 is seeking a detail-oriented Farmacéutico de Asuntos Regulatorios in Aguascalientes to lead regulatory submissions, maintain compliance, and liaise with COFEPRIS and other health authorities. You will prepare dossiers, monitor changes, and guide cross-functional teams through the product lifecycle.

The ideal candidate has a pharmacy degree, 3–5 years in regulatory affairs, strong Spanish and English, and proficiency with regulatory information systems.