Regulatory affairs specialist

PIERRE FABRE FARMA DE MEXICO SA DE CV; Occitanie; Hybrid; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Annual bonus

Superior benefits package

Hybrid work model

Job summary

PIERRE FABRE FARMA DE MEXICO SA DE CV is seeking a Regulatory Affairs professional to lead registrations, variations, and renewals for medicines and dermo-cosmetic products in Mexico and Central America.

The role requires a QFB degree, at least 3 years in Regulatory Affairs, and strong knowledge of COFEPRIS regulations. You will liaise with authorities and partner cross-functionally across Marketing, Quality, and Supply Chain.

Qualifications

• Pharmaceutical Chemist Biologist (QFB) or related degree.
• Minimum 3 years in Regulatory Affairs.
• Mandatory experience in pharmaceutical and dermo-cosmetic industry.
• Knowledge of Central American and Mexican regulatory frameworks.
• Autonomous professional with solid decision-making skills.
• Technical Knowledge COFEPRIS regulations Maquila notifications Internal corrections management Advertising regulatory compliance.

Responsibilities

• Prepare regulatory dossiers for new registrations, variations, and renewals of medicinal products.
• Manage advertising and promotional materials for pharmaceutical and dermo-cosmetic products.
• Follow up and implement packaging changes for medicines and cosmetics.
• Interact with regulatory authorities (COFEPRIS and Central American agencies).
• Collaborate cross-functionally with Marketing, Supply Chain, Quality, and Medical teams.

Skills

Regulatory knowledge

Cross-functional collaboration

Autonomy

Decision making

Education

QFB (Pharmaceutical Chemist Biologist) or related degree

Job description

Who we are?

The Pierre Fabre Group is unique in France: 2nd Dermo-Cosmetics laboratory in the world and 2nd private French Pharmaceutical group. Our group is 86% owned by the Pierre Fabre Foundation, recognized as being of public utility by the French government and which is dedicated to improving access to quality care and medicines in the least favored countries. This original shareholders structure ensures the independence of the company. Our mission: "Every time we take care of one person, we make the world a better place. "To achieve this, we cooperate with healthcare professionals, our trusted partners around the world, relesentlessly drawing inspiration from nature and plants, and placing pharmaceutical ethics at the very heart of our operations. We are established in 45 countries and in more than 130 countries thanks to distribution agreements. Opening up to the international market has always been at the heart of our strategy. Our head office is located in a region that is close to our hearts: Occitanie, in particular the Tarn department, where the group was founded and has been established since its inception. Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expressionand identuty, disability, or any other kind of discrimination. You can find more about us here

Your mission

We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the “We Care Movement,” a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all — because every time we care for a single person, we make the whole world better.

Key Responsibilities

• Prepare regulatory dossiers for new registrations, variations, and renewals of medicinal products.
• Manage advertising and promotional materials for pharmaceutical and dermo-cosmetic products.
• Follow up and implement packaging changes for medicines and cosmetics.
• Interact with regulatory authorities (COFEPRIS and Central American agencies).
• Collaborate cross-functionally with Marketing, Supply Chain, Quality, and Medical teams.

Scope: Mexico, Dominican Republic, Honduras, and Guatemala

Requirements

• Education QFB (Pharmaceutical Chemist Biologist) or related degree.
• Experience Minimum 3 years in Regulatory Affairs.
• Mandatory experience in pharmaceutical and dermo-cosmetic industry.
• Knowledge of Central American and Mexican regulatory frameworks.
• Autonomous professional with solid decision-making skills.
• Technical Knowledge COFEPRIS regulations Maquila notifications Internal corrections management Advertising regulatory compliance

What We Offer

Base salary Annual bonus equivalent to one month of salary Superior benefits package Hybrid work model

About Us

Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow. If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement.”

Diversity & Inclusion

At Pierre Fabre Laboratories, we believe that our greatest asset is our people. We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. We are convinced that diversity is a source of fulfillment, social balance, and complementarity for our employees, which is why our offers are open to all, without restriction.

Who you are?

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction. Pierre Fabre Laboratories is the world’s second-largest dermo-cosmetics company and one of Europe’s leading pharmaceutical laboratories. Our Dermo-cosmetics & Personal Care portfolio includes international brands such as Eau Thermale Avène, Ducray, Klorane, A-Derma, René Furterer, Même Cosmetics, Darrow and Elgydium. The Medical Care activity covers 5 main therapeutic fields: oncology, dermatology, rare diseases, primary care and family health care. By choosing Pierre Fabre Laboratories, you will join a company where the human dimension is essential, where excellence and innovation are valued, within passionate teams united by common values, committed to pushing the boundaries of science to unite health and beauty for the benefit of all, because every time we care for a single person, we make the whole world better.