Back to jobs
Job Description
• Leading all regulatory submissions to Mexican Health Authorities, including NDAs, product variations, renewals, promotional materials, and import licenses
• Developing and executing regulatory strategies that balance speed-to-market with compliance excellence
• Planning and conducting regulatory interactions with COFEPRIS, including technical meetings and New Molecules Committee presentations
• Coordinating regulatory intelligence to assess emerging regulations and competitive landscape, providing risk and impact assessments
• Maintaining core labelling throughout the product lifecycle and ensuring promotional materials meet both internal and external regulatory standards
• Acting as the regulatory subject matter expert for cross-functional teams across the Mexican affiliate and collaborating with HQ, International Operations, and LATAM regulatory groups
• Mentoring colleagues with less experience and contributing to continuous improvement of regulatory processes
• Developing and executing regulatory strategies that balance speed-to-market with compliance excellence
• Planning and conducting regulatory interactions with COFEPRIS, including technical meetings and New Molecules Committee presentations
• Coordinating regulatory intelligence to assess emerging regulations and competitive landscape, providing risk and impact assessments
• Maintaining core labelling throughout the product lifecycle and ensuring promotional materials meet both internal and external regulatory standards
• Acting as the regulatory subject matter expert for cross-functional teams across the Mexican affiliate and collaborating with HQ, International Operations, and LATAM regulatory groups
• Mentoring colleagues with less experience and contributing to continuous improvement of regulatory processes