Remote Regulatory Affairs & Quality Lead for New Drugs

Placements24; Chihuahua; Hybrid; MXN 900,000 - 1,200,000; Full time

Benefits offered by this job

Remote work

Health benefits

Professional development allowance

Competitive compensation

Job summary

Placements24 is seeking a Pharmaceutical Regulatory Affairs and Quality Specialist for New Product Development. This fully remote role guides products from development to market, shaping regulatory strategy and ensuring quality across the lifecycle from Chihuahua, Mexico and beyond.

You will lead submissions to COFEPRIS, FDA, EMA and other authorities, collaborate with R&D, QA, manufacturing, and clinical teams, and ensure GMP/GCP/GLP compliance to deliver innovative medicines.

Qualifications

• Advanced degree in a relevant scientific field and active license is preferred.
• Minimum 6 years in pharmaceutical regulatory affairs with NPD focus.
• Proven track record in global regulatory submissions and approvals.

Responsibilities

• Provide strategic regulatory guidance for new product development projects.
• Develop and execute strategies for timely approvals by COFEPRIS, FDA, EMA.
• Prepare, review, and submit regulatory dossiers for new marketing authorizations.
• Collaborate with R&D, quality, manufacturing and clinical teams on regulatory needs.
• Ensure development activities meet GMP, GCP and GLP standards.
• Monitor regulatory changes and advise on impact on programs.
• Manage lifecycle commitments and post-approval regulatory tasks.
• Serve as primary contact for agencies during reviews.
• Contribute to quality management systems for new product introduction.

Skills

Regulatory affairs

GMP/GCP/GLP

Regulatory submissions

Global regulations

Cross-functional leadership

Education

Advanced degree in Pharmacy, Chemistry, Biology, or related field

Job description

Placements24 is seeking a Pharmaceutical Regulatory Affairs and Quality Specialist for New Product Development. This fully remote role guides products from development to market, shaping regulatory strategy and ensuring quality across the lifecycle from Chihuahua, Mexico and beyond.

You will lead submissions to COFEPRIS, FDA, EMA and other authorities, collaborate with R&D, QA, manufacturing, and clinical teams, and ensure GMP/GCP/GLP compliance to deliver innovative medicines.