About the Role

Our client, an innovative pharmaceutical company focused on bringing novel therapies to market, is seeking a highly skilled Pharmaceutical Regulatory Affairs and Quality Specialist for New Product Development. This role, operating fully remotely, is crucial for guiding new drug products through the complex regulatory landscape from development to market approval. You will provide strategic regulatory input, ensure quality standards are met throughout the development lifecycle, and manage submissions to health authorities, focusing on launching impactful medicines in Chihuahua, Chihuahua and beyond. This is an opportunity to shape the future of pharmaceutical innovation.

Key Responsibilities

- Provide strategic regulatory guidance for new product development projects, from early-stage research to late-stage clinical trials.
- Develop and execute regulatory strategies to achieve timely approvals from national and international health authorities (e.g., COFEPRIS, FDA, EMA).
- Prepare, review, and submit high-quality regulatory dossiers for new marketing authorization applications.
- Collaborate closely with R&D;, quality assurance, manufacturing, and clinical teams to ensure alignment on regulatory and quality requirements.
- Ensure that all development activities and documentation meet stringent quality standards and comply with GMP, GCP, and GLP.
- Monitor the evolving regulatory environment and provide insights on potential impacts to development programs.
- Manage post-approval regulatory commitments and lifecycle management for approved products.




- Serve as the primary point of contact for regulatory agencies during the review process.
- Contribute to the development of quality management systems relevant to new product introduction.

Requirements

- Advanced degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Valid and current pharmacist license in Mexico is highly preferred.
- Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs, with a significant focus on new product development and submissions.
- Proven track record of successful regulatory submissions and approvals for innovative pharmaceutical products.
- Expert knowledge of integral regulatory requirements and guidelines (e.g., ICH, FDA, EMA, COFEPRIS).
- Deep understanding of quality assurance principles and GMP/GCP/GLP.
- Excellent strategic thinking, analytical, and problem-solving skills.
- Exceptional written and verbal communication and negotiation skills.
- Ability to lead cross-functional teams and manage complex projects in a remote environment.

Benefits

This fully remote role offers a highly competitive salary and bonus structure, comprehensive health and wellness benefits, and a generous allowance for professional development. You will have the autonomy to manage your workload and collaborate with a world-class team from the comfort of your home office, contributing significantly to bringing life-changing medicines to patients. Our client values innovation, collaboration, and employee well-being, providing a stimulating and rewarding career experience.

📌 Farmacéutico de Asuntos Regulatorios y Calidad para Nuevos Productos (Chihuahua)
🏢 Placements24
📍 Chihuahua