Regulatory Affairs Lead LATAM

Pharmanovia; Ciudad de México; Presencial; MXN 80.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Bonus and rewards package

Pension scheme

Hybrid working

Descripción de la vacante

Pharmanovia, a fast-growing pharmaceutical company in Mexico City, is seeking a Regulatory Affairs Lead to oversee its LATAM functions. This role involves developing compliance strategies, managing product registrations, and influencing regional regulatory frameworks.

The ideal candidate holds a Master’s degree in Pharmacy with at least 5 years in Regulatory Affairs, demonstrating expertise in LATAM regulations, particularly within COFEPRIS. Strong communication skills in English and Spanish are essential for success in this strategic position.

Formación

• Minimum 5 years’ Regulatory Affairs experience within a multinational pharmaceutical organisation.
• Experience in product registrations, lifecycle management, and compliance.

Responsabilidades

• Lead Regulatory Affairs function across LATAM and align with global objectives.
• Develop strategies for product registrations and market expansion.
• Provide regulatory input into business development and licensing opportunities.

Conocimientos

Proven experience developing and executing regulatory strategies

Strong knowledge of COFEPRIS regulations

Excellent written and verbal communication skills

Excellent scientific writing skills

Advanced Microsoft Office skills

Educación

Master’s degree in Pharmacy or related field

Descripción del empleo

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

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 2013, 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 global 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, present, and defend complex regulatory strategies to internal stakeholders, partners, and health authorities.
• Experience working within cross‑functional global teams and influencing stakeholders across multiple functions and geographies.
• Excellent scientific writing skills with experience preparing regulatory submissions, technical documentation, briefing packages, and strategic regulatory assessments.
• Excellent verbal and written communication skills in both English and Spanish.
• Advanced Microsoft Office skills, including Excel and PowerPoint.

Preferred Skills

• Experience establishing or leading regional regulatory functions.
• Experience managing external regulatory consultants, vendors, and regional partners.
• Exposure to multiple LATAM markets beyond Mexico.
• Experience within speciality pharmaceutical, branded medicines, or innovative pharmaceutical environments.
• Previous people‑leadership or matrix‑leadership experience.
• Experience supporting products within Cardiovascular, Oncology, Endocrinology, or Neurology therapeutic areas.

Pay range and compensation Package

We offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid working.

Equal Opportunity Statement

Pharmanovia is an equal‑opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Pharmanovia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.