Regulatory Affairs Coordinator

Elysian Biologics; Ciudad de México; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

Una empresa innovadora en el sector farmacéutico busca un Coordinador de Asuntos Regulatorios apasionado por mejorar la vida de los pacientes. En este papel, serás responsable de asegurar el cumplimiento de las normativas nacionales e internacionales, gestionando presentaciones y manteniendo la documentación actualizada para la gestión del ciclo de vida del producto. Colaborarás con diferentes departamentos y te involucrarás activamente con las autoridades regulatorias. Si tienes una sólida experiencia en la industria farmacéutica y un deseo de marcar la diferencia, esta es la oportunidad perfecta para ti.

Formación

• Mínimo 8 años de experiencia en la industria farmacéutica en América Latina.
• Experiencia en la presentación de solicitudes para productos genéricos y biosimilares.

Responsabilidades

• Coordinar presentaciones regulatorias a las autoridades de salud correspondientes.
• Garantizar el cumplimiento de las regulaciones nacionales e internacionales.

Conocimientos

Conocimiento de estándares regulatorios nacionales

Habilidades de negociación

Comunicación efectiva

Compilación y revisión de dossiers

Educación

Licenciatura en Química

Licenciatura en Farmacia

Licenciatura en Ciencias Farmacéuticas

Descripción del empleo

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About Elysian Biologics:

At Elysian Biologics, we are committed to making life better for patients. Our mission is to improve access to life-changing medicines and enhance the understanding and management of diseases. We are looking for passionate individuals who are determined to make a positive impact on the lives of patients.

About the Role:

The Regulatory Affairs Coordinator will ensure compliance with national and international regulations, managing submissions and maintaining up-to-date documentation for product registration and lifecycle management. This role requires collaboration across departments and active engagement with regulatory authorities.

Responsibilities:

1. Ensure and coordinate regulatory submissions to the relevant health authorities.
2. Guarantee compliance with applicable national and international regulations.
3. Review regulatory changes and assess their impact on company operations.
4. Monitor responses to regulatory inquiries and resolve pending issues.
5. Train staff on applicable regulations and updates in regulatory requirements.

Qualifications:

1. Bachelor's degree in Chemistry, Pharmacy, Pharmaceutical Chemistry Biology (QFB), Pharmaceutical Sciences (LCF), or related fields.
2. Strong knowledge of national regulatory standards (COFEPRIS).
3. Minimum 8 years of proven experience in the pharmaceutical industry in Latin America in Regulatory Affairs roles or related positions.
4. Experience submitting applications for generic and biosimilar products, innovative drugs, and medical devices.
5. Strong skills in negotiation and effective communication.
6. Hands-on experience in compiling, reviewing, and submitting dossiers and managing product lifecycle compliance with regulatory authorities.
7. Business proficiency in English is required.
8. Desirable: Knowledge of international regulatory standards (FDA, ANVISA, INVIMA, Central America, and the Caribbean).

Seniority level

Associate

Employment type

Full-time

Job function

Administrative

Industries

Pharmaceutical Manufacturing, Retail Pharmacies, and Biotechnology Research