Regulatory Affairs Manager (Biotech)

Location: Bogotá, Colombia

Company

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

What you will do

• Own regulatory strategy and product lifecycle management for the assigned portfolio in Colombia.
• Plan, prepare, submit, track, and obtain approvals for sanitary registrations, post-approval changes, renewals, indication extensions, and labeling updates.
• Act as the primary local regulatory contact with INVIMA, the Ministry of Health and Social Protection, and other relevant authorities.
• Assess regulatory risks and opportunities, define mitigation plans, and advise Global, Regional, and Local teams on business, supply, compliance, and patient-access impacts.
• Coordinate implementation of labeling changes and regulatory requirements related to product supply, manufacturing, quality, importation, and documentation.
• Lead regulatory information management improvements, manage external providers, and coach peers and cross-functional partners.

Requirements

• Professional degree in Pharmacy or a related scientific discipline.
• At least 7 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, including at least 2 years managing regulatory submissions and product lifecycle activities with minimal supervision.
• Strong knowledge of Colombian pharmaceutical legislation, INVIMA processes, and requirements for innovative medicines, biological products, biosimilars, and small molecules.
• Fluency in Spanish and professional proficiency in English are required.
• Experience with regulatory submissions, labeling and packaging, promotional compliance, health-authority engagement, and product supply activities.
• Strong strategic thinking, risk assessment, problem-solving, prioritization, communication, and cross-functional collaboration skills.

Nice to have

• Experience engaging with INVIMA across the lifecycle of biologics, biosimilars, and small molecules.
• Experience leading external engagement and negotiating solutions for complex regulatory issues.
• Experience with regulatory and competitive intelligence, data analytics, regulatory information management systems, and collaboration tools.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Competitive benefits and a comprehensive total rewards plan aligned with local industry standards.
• Support for professional growth, personal well-being, and inclusive teamwork.
• Equal opportunity employment and reasonable accommodations during the hiring process and employment.