RIO Execution Hub Sr. Associate (Regulatory Affairs)

Location: Mexico City, Mexico; hybrid work arrangement

Company

hirify.global is a pharmaceutical company developing and delivering medicines and related healthcare products.

What you will do

• Manage multi-regional, regional, and national regulatory dossiers from initial registration applications through lifecycle management and product withdrawal.
• Coordinate with submission managers, regional hubs, labeling teams, clusters, countries, and subject matter experts to deliver regulatory applications and lifecycle changes.
• Author and review local M1 dossier documents, including cover letters, variations, marketing authorization applications, and relevant translations.
• Prepare and review dossier tables of contents, support health authority query responses, and coordinate responses to complex regulatory requests.
• Identify and escalate quality, compliance, and emerging risks while supporting audit readiness, launch planning, tenders, and product quality activities.
• Implement portfolio execution efficiencies and contribute subject matter expertise to projects affecting RIO Hub people, technology, and processes.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Business, or Information Technology is desirable; equivalent relevant professional experience is considered.
• Advanced to fluent English is required.
• Technical aptitude and the ability to quickly learn new software, regulations, and quality standards.
• Self-directed problem-solving skills, sound judgment in ambiguous situations, and the ability to recognize when escalation is required.
• Advanced Microsoft Office Suite skills.
• Relevant experience in pharmaceutical regulatory, quality, or compliance functions is preferred.

Nice to have

• Multilingual skills.
• Familiarity with pharmaceutical organizational structures, systems, and culture.
• Understanding of country or cluster regulatory requirements and trends.

Culture & Benefits

• Full-time employment with a hybrid work arrangement.
• Work focused on timely, high-quality, compliant, and efficient regulatory delivery.
• Equal employment opportunity regardless of race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, or disability.