Farmacéutico Consultor en Regulatorio

Placements24; San Luis Potosí; Hybrid; MXN 1,671,000 - 2,228,000; Full time

Job summary

Placements24 is seeking an experienced Farmacéutico Consultor en Regulatorio to provide expert guidance to pharmaceutical companies. This fully remote contract role offers flexibility and exposure to diverse regulatory projects, including NDAs, ANDAs, and variations, with emphasis on COFEPRIS and international regulations.

You will advise clients on navigating regulatory landscapes, preparing submission dossiers, and ensuring compliance while working remotely with international clients.

Qualifications

• Pharm.D. or an equivalent advanced degree.
• At least 10 years of progressive experience in pharmaceutical regulatory affairs.
• Experience preparing and submitting regulatory dossiers to major health authorities.
• Knowledge of COFEPRIS and international regulations (FDA, EMA).
• Remote, client-facing role with ability to manage multiple projects.

Responsibilities

• Provide strategic regulatory advice for product registration and lifecycle management.
• Prepare and review regulatory submission dossiers for health authorities.
• Interpret and apply regulatory guidelines for pharmaceutical products.
• Liaise with regulatory agencies on behalf of clients to facilitate approvals.
• Develop regulatory strategies aligned with client objectives.
• Manage multiple client projects remotely with timely delivery.

Skills

Regulatory affairs

Strategic thinking

Project management

Communication skills

Education

Pharm.D.

Job description

About the Role

Our client, a dynamic pharmaceutical consulting firm specializing in regulatory affairs, is seeking an experienced Farmacéutico Consultor en Regulatorio to provide expert guidance to pharmaceutical companies. This is a fully remote contract position, offering significant flexibility and the opportunity to work on diverse and challenging projects. You will advise clients on navigating complex regulatory landscapes, preparing submission dossiers, and ensuring compliance with local and international health authority requirements. Our firm is known for its high-impact strategic advice and deep industry expertise. If you have a strong background in regulatory affairs and a passion for helping companies bring safe and effective medicines to market, this is an ideal role for you.

Key Responsibilities

• Provide strategic regulatory advice to clients for product registration and lifecycle management.
• Prepare and review regulatory submission dossiers (e.g., NDAs, ANDAs, variations) for submission to health authorities.
• Interpret and apply relevant regulatory guidelines and legislation for pharmaceutical products.
• Conduct regulatory intelligence activities to stay updated on evolving requirements.
• Liaise with regulatory agencies on behalf of clients, addressing queries and facilitating approvals.
• Develop and implement regulatory strategies aligned with clients' business objectives.
• Assist clients in developing and maintaining regulatory compliance programs.
• Conduct due diligence assessments for mergers and acquisitions from a regulatory perspective.
• Train client personnel on regulatory requirements and best practices.
• Manage multiple client projects simultaneously, ensuring timely delivery and high-quality outcomes.

Requirements

• Doctorado en Farmacia (Pharm.D.) or equivalent advanced degree in a related scientific field.
• Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record in preparing and submitting regulatory dossiers to major health authorities.
• In-depth knowledge of Mexican regulatory requirements (COFEPRIS) and familiarity with international regulations (FDA, EMA) is essential.
• Strong understandig of pharmaceutical development, manufacturing, and quality systems.
• Excellent analytical, strategic thinking, and problem-solving skills.
• Exceptional written and verbal communication skills in Spanish and English.
• Demonstrated ability to manage projects independently and work effectively in a remote, client-facing role.
• High level of integrity and ethical conduct.
• Experience in specific therapeutic areas is a plus.

Benefits

This contractor role offers a highly competitive compensation package, commensurate with experience and project scope. You will have the flexibility to work remotely and choose projects that align with your expertise. Join a leading consultancy that empowers its professionals and contributes to significant advancements in the pharmaceutical industry.