Regulatory Affairs Manager (CDMX)

Location: Mexico City, Mexico

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead local regulatory strategies and filing plans for assigned products throughout their lifecycle.
• Plan, submit, track, and secure approvals for marketing authorizations, variations, renewals, extensions, administrative changes, and labeling updates.
• Act as the primary regulatory interface with COFEPRIS, coordinating meetings, responses, technical clarifications, and other Health Authority interactions.
• Assess regulatory risks and define mitigation strategies affecting business priorities, product supply, compliance, and patient access.
• Partner with Global, Regional, Quality, Safety, Medical, Clinical Development, Supply Chain, Access, Legal, Compliance, and Commercial functions.
• Drive process improvements, manage external consultants where applicable, and lead knowledge sharing and resource prioritization.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related scientific discipline.
• At least 7 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Proficiency in English in oral and written communication.
• Experience with regulatory submissions and product lifecycle activities in Mexico, including COFEPRIS interactions.
• Knowledge of Mexican pharmaceutical legislation, COFEPRIS processes, and requirements for innovative medicines, biologics, biosimilars, and small molecules.
• Strong risk assessment, problem-solving, prioritization, communication, negotiation, and cross-functional collaboration skills.

Nice to have

• Experience registering biologics, biosimilars, innovative medicines, or products requiring complex post-approval changes.
• Experience with labeling development and implementation in Mexico.
• Ability to translate complex scientific, technical, and regulatory information into actionable recommendations for senior stakeholders.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Competitive base salary and comprehensive total rewards aligned with local industry standards.
• Inclusive workplace focused on professional growth, personal well-being, ethical conduct, and diversity.
• Opportunity to contribute to medicines that improve the lives of patients with serious illnesses.