About the Role

Our client is seeking a meticulous and knowledgeable Farmacéutico Regulador y de Cumplimiento (Regulatory Affairs Pharmacist) to join their team in Tuxtla Gutiérrez, Chiapas . This hybrid role is essential for ensuring that all pharmaceutical products and operations comply with national and international regulatory standards. You will play a key role in preparing regulatory submissions, liaising with health authorities, and maintaining compliance throughout the product lifecycle. We are looking for a detail-oriented professional with a strong understanding of pharmaceutical regulations and a commitment to upholding the highest standards of quality and safety. Your expertise will be vital in navigating the complex regulatory landscape and facilitating market access for our client's products. This position offers an exciting opportunity to contribute to a critical function within the pharmaceutical industry, ensuring that safe and effective medicines reach patients. The hybrid nature of the role offers a balance of focused work and collaborative interaction.

Key Responsibilities

- Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities (e.g., COFEPRIS).
- Monitor and interpret changes in pharmaceutical regulations and guidelines, assessing their impact on the company's operations.
- Serve as a key point of contact for regulatory agencies during inspections and inquiries.
- Ensure that all marketing materials, labeling, and product information comply with regulatory requirements.
- Collaborate with R&D;, manufacturing, quality assurance, and marketing teams to ensure regulatory compliance throughout product development and commercialization.




- Manage post-approval regulatory activities, including safety reporting and compliance updates.
- Conduct regulatory due diligence for potential partnerships or acquisitions.
- Provide regulatory guidance and training to internal stakeholders.
- Maintain regulatory databases and ensure accurate record-keeping.

Requirements

- Licensed Pharmacist in Mexico with active registration.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs or a related compliance role.
- In-depth knowledge of Mexican pharmaceutical regulations (COFEPRIS) and familiarity with international regulations (e.g., FDA, EMA) is a plus.
- Proven experience in preparing and submitting regulatory dossiers.
- Strong understanding of drug development processes, manufacturing, and quality assurance.
- Excellent analytical, problem-solving, and organizational skills.
- Effective written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Ability to work effectively in a hybrid model, managing tasks independently and collaborating effectively.
- High level of attention to detail and commitment to accuracy.

Benefits

- Our client offers a competitive salary and a comprehensive benefits package, including health insurance, life insurance, and opportunities for professional development.
- This hybrid role provides the flexibility to manage your work effectively while contributing to a vital function within the pharmaceutical industry.
- You will have the chance to work on diverse projects and collaborate with cross-functional teams, expanding your expertise in regulatory affairs.
- We foster a supportive and professional work environment in Tuxtla Gutiérrez, Chiapas .

#J-18808-Ljbffr

📌 Farmacéutico Regulador y de Cumplimiento (Regulatory Affairs Pharmacist) (Tuxtla Gutiérrez)
🏢 Placements24
📍 Tuxtla Gutiérrez