Farmacéutico de Asuntos Regulatorios Farmacéuticos en Aguascalientes

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

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking a detail-oriented and experienced Farmacéutico de Asuntos Regulatorios to join their team in Aguascalientes, Aguascalientes . This role is vital for ensuring that all pharmaceutical products meet stringent regulatory standards for approval and marketing, both domestically and internationally. The ideal candidate will possess a comprehensive understanding of pharmaceutical regulations, submission processes, and health authority requirements. You will play a key role in navigating the complex regulatory landscape, facilitating the timely approval of new products and maintaining compliance for existing ones. This position offers a challenging and rewarding career in a dynamic sector, contributing to patient access to safe and effective medicines. Our client fosters a culture of integrity, compliance, and continuous learning, providing excellent opportunities for professional development. Join a team that is committed to excellence and making a significant impact on public health.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) for new drug applications and variations to health authorities.
• Liaise directly with regulatory agencies (e.g., COFEPRIS, FDA, EMA) to facilitate the review process and respond to queries.
• Ensure compliance with all applicable national and international pharmaceutical regulations and guidelines.
• Manage post-approval regulatory activities, including amendments, renewals, and annual reports.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to gather necessary information for submissions.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.
• Review promotional materials and labeling to ensure regulatory compliance.
• Maintain regulatory databases and documentation systems.
• Participate in regulatory inspections and audits.

Requirements

• Bachelor's degree in Pharmacy or a related scientific field.
• Master's degree or specialized training in regulatory affairs is a plus.
• Minimum of 3-5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of pharmaceutical regulations in Mexico (COFEPRIS) and familiarity with major international markets (e.g., FDA, EMA).
• Proven experience in preparing and submitting regulatory dossiers for pharmaceutical products.
• Strong understanding of the drug development process and product lifecycle management.
• Excellent analytical, organizational, and problem-solving skills.
• Exceptional written and verbal communication skills in Spanish.
• Professional proficiency in English is essential.
• Ability to work effectively under pressure and meet strict deadlines.
• Proficiency in regulatory information management systems (RIMS) and common office software.
• Strong interpersonal skills and ability to build relationships with regulatory authorities and internal stakeholders.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan.
• Paid time off and holidays.
• Opportunities for professional development, regulatory training, and conferences.
• Exposure to a wide range of pharmaceutical products and markets.
• Collaborative work environment with a team of regulatory experts.
• Support for continuous learning and career growth.
• Direct contribution to bringing essential medicines to patients.
• Work-life balance initiatives.