**Regulatory Affairs Lead LATAM - Full Time - Remote - Based in Mexico City****About the Company**Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets.Our mission is to improve patient health globally by revitalising niche, tried-and-trusted medicines.Since its inception in ****, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers worldwide.Our growth has enabled the company to reinvest in its products, brands, people, and communities.Today, Pharmanovia employs more than 300 colleagues representing 29 nationalities and operates across Europe, the Middle East, Asia-Pacific, and Latin America.Our core therapeutic areas include Cardiovascular, Oncology, Endocrinology, and Neurology.We are an agile, entrepreneurial, and innovative speciality pharmaceutical company committed to maximising the value of established and speciality medicines while improving patient access worldwide.
**About the Role**We are seeking an experienced Regulatory Affairs Lead, LATAM, to establish and lead Pharmanovia's regional regulatory function and drive the execution of our ambitious growth strategy across Latin America.Reporting to the Head of Regulatory Affairs, this highly visible role will serve as the regional regulatory expert, responsible for developing and executing regulatory strategies to support product registrations, lifecycle management, compliance, and business development across the LATAM region.Working closely with Global Regulatory Affairs, Scientific Affairs, Commercial Leadership, Business Development, and local partners, you will play a critical role in enabling product launches, identifying growth opportunities,



and ensuring regulatory excellence across the region.This position offers the opportunity to build and shape the LATAM regulatory framework while acting as a key strategic partner to the business.
**Responsibilities**- Lead and establish Pharmanovia's Regulatory Affairs function across LATAM, ensuring alignment with integral business objectives and regional growth strategies.
- Develop and execute regulatory strategies to support product registrations, lifecycle management, market expansion, and new product launches.
- Drive the successful approval and commercialisation of new products through effective management of CTA, CTA exemption, NDA, variation, renewal, and post-approval submissions.
- Act as the primary regulatory representative for LATAM, providing strategic regulatory leadership across cross-functional project teams.
- Build and maintain strong relationships with regional health authorities, including COFEPRIS and other national competent authorities across Latin America.
- Lead all interactions, negotiations, submissions, and regulatory communications with health authorities to ensure successful outcomes.
- Provide strategic regulatory input into business development, licensing opportunities, due diligence assessments, acquisitions, and portfolio expansion activities.
- Ensure full regulatory compliance for all marketed products and development activities across LATAM markets.




- Develop regulatory pathways and market access strategies that optimise time-to-market and maximise commercial opportunities.
- Monitor changes in regulations, guidance, and industry trends, proactively assess business impact, and implement necessary actions.
- Lead regulatory planning and submission activities, ensuring high-quality dossiers are delivered within agreed timelines.
- Provide expert guidance on product labelling, artwork approvals, lifecycle management, and change control activities.
- Support the registration and maintenance of foreign-developed pharmaceutical products within LATAM markets.Collaborate closely with Commercial, Medical Affairs, Quality, Supply Chain, Pharmacovigilance, and Scientific Affairs teams to ensure successful product development and commercialisation.
**Qualifications**- Master's degree or higher in Pharmacy, Pharmaceutical Sciences, Medicine, Chemistry, Life Sciences, or a related scientific discipline.
- Minimum 5 years' Regulatory Affairs experience within a multinational pharmaceutical organisation.
**Required Skills**:- Proven experience developing and executing CTA, CTA exemption, NDA, registration, and lifecycle management strategies across LATAM markets.
- Strong knowledge of COFEPRIS regulations and the broader LATAM regulatory environment.
- Demonstrated experience supporting pharmaceutical product registrations, variations, renewals, and post-approval activities.
- Strong understanding of the regulatory infrastructure required for the commercialisation and distribution of pharmaceutical products.
- Experience leading regulatory strategies that support new product launches and portfolio expansion initiatives.
- Ability to independently develop, presen

📌 Regulatory Affairs Lead Latam (Xico)
🏢 Pharmanovia
📍 Xico