Regulatory Affairs Lead LATAM - Full-Time - Remote - Based in Mexico City

We are seeking an experienced Regulatory Affairs Lead to oversee regulatory strategy, submissions and compliance activities across Latin America. This role will lead regional regulatory planning, support product registrations and lifecycle management, coordinate interactions with health authorities and provide strategic regulatory guidance to cross-functional teams. The successful candidate will have strong knowledge of pharmaceutical regulations across LATAM, excellent stakeholder management skills and the ability to navigate complex regulatory environments.

Regulatory Affairs Lead - Key responsibilities (LATAM regulatory strategy and submissions)

• Develop and implement regulatory strategies and operating plans for Latin American markets, aligned with global objectives, product priorities and applicable local requirements.

• Lead regional regulatory planning for new product registrations, line extensions, variations, renewals, transfers and other lifecycle management activities.

• Coordinate the preparation, review, submission and maintenance of regulatory dossiers and supporting documentation across LATAM.

• Manage regulatory submissions and approval activities with national health authorities, including ANVISA, COFEPRIS, INVIMA, ISP, DIGEMID and other relevant agencies.

• Provide regulatory input into product development, clinical programmes, labelling, packaging, artwork, promotional materials and market launch planning.

• Monitor changes in pharmaceutical legislation, regulatory guidance, health authority expectations and industry standards across Latin American markets.

• Assess regulatory requirements, risks and opportunities associated with new products, business development activities, market expansion and portfolio changes.

• Prepare clear regulatory assessments, submission plans, briefing documents, responses to authority questions and status reports for internal stakeholders.

• Lead responses to health authority queries, deficiency letters, requests for information and other regulatory correspondence within agreed timelines.

• Build and maintain effective relationships with health authorities, regulatory consultants, local representatives, distributors and other external partners.

• Work closely with global regulatory affairs, medical, clinical, quality, pharmacovigilance, supply chain, legal, commercial and marketing teams.

• Review and approve regulatory content for product information, technical materials, promotional communications and customer-facing documents, where applicable.

• Establish effective regulatory processes, reporting standards, submission-tracking systems, and performance dashboards for the LATAM region.

• Support regulatory inspections, audits, compliance reviews and corrective or preventive actions as required.

• Ensure all regulatory activities comply with applicable laws, health authority requirements, company policies, quality standards and ethical business practices.

Required skills and experience (LATAM regulatory affairs and pharmaceutical registrations)

• Proven experience in regulatory affairs within the pharmaceutical, biotechnology, medical device, healthcare or life sciences sector.

• Demonstrable experience managing regulatory submissions and product registrations across multiple Latin American markets.

• Strong knowledge of regional regulatory frameworks, submission procedures, technical requirements and health authority interactions in LATAM.

• Experience with new product registrations, variations, renewals, post-approval changes, product transfers and lifecycle management.

• Experience preparing, reviewing and maintaining dossiers in applicable formats, including CTD or eCTD where required.

• Understanding of pharmaceutical labelling, packaging, artwork, promotional compliance, pharmacovigilance and quality requirements.

• Ability to interpret regulatory legislation and guidance, assess impact and translate requirements into practical regulatory plans.

• Experience managing health authority questions, deficiency responses, commitments, timelines and submission-related risks.

• Strong project management skills, with the ability to coordinate multiple submissions and priorities across different countries.

• Excellent written and verbal communication, negotiation and stakeholder management skills.

• Proficiency in Microsoft Office; experience with regulatory information management systems, electronic submission platforms or document management systems is advantageous.

• Availability and flexibility to collaborate across different time zones and travel within Latin America as required.

Qualifications and professional attributes (regional regulatory leadership and compliance)

• Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Medicine or a related discipline; a postgraduate qualification in regulatory affairs or a relevant field is desirable.

• Fluency in English, both written and spoken; Spanish and/or Portuguese language skills are essential or highly advantageous depending on market responsibilities.

• Strong understanding of regulatory processes and requirements across diverse Latin American markets.

• Strategic, analytical and detail-oriented, with the ability to balance regulatory compliance, business priorities and patient needs.

• Confident decision-maker with the ability to manage ambiguity, assess risk and provide clear recommendations to senior stakeholders.

• Highly organised and results-oriented, with the ability to manage complex projects and deliver high-quality work within strict timelines.

• Collaborative and adaptable, with the ability to work effectively across cultures, functions and levels of an international organisation.

• Committed to scientific integrity, regulatory compliance, transparency and ethical engagement with health authorities and external partners.

What we offer (benefits and career development)

• Competitive salary and performance-related bonus.

• Company pension scheme, private healthcare and life insurance.

• Flexible working options and support for effective international collaboration.

• Professional development, training and opportunities to build expertise in regulatory affairs, pharmaceutical registrations and LATAM market requirements.

• Opportunity to shape regional regulatory strategy and support the successful development and commercialisation of healthcare products across Latin America.

• Inclusive international workplace culture with emphasis on wellbeing, collaboration and work-life balance.

How to apply (application process and equal opportunities)

Please submit your CV and a cover letter outlining your relevant regulatory affairs experience across Latin America, including examples of product registrations, successful submissions, health authority interactions and lifecycle management activities. We are an equal opportunities employer and welcome applications from candidates of all backgrounds. Only shortlisted applicants will be contacted.