Regulatory Affairs Officer - Cmc

buscojobs España; Murcia; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

Una empresa multinacional de consultoría en la industria farmacéutica busca un Oficial de Asuntos Regulatorios para su unidad de CMC. El candidato ideal tendrá experiencia en la gestión de dossiers, con habilidades analíticas y un enfoque en la calidad y el servicio al cliente. Ofrecemos un entorno flexible, con oportunidades de desarrollo personal y un equipo diverso.

Servicios

Horas de trabajo flexibles

Modelo híbrido o remoto

Programas de desarrollo personal

Ambiente inclusivo y de alto rendimiento

Programas de bienestar

Formación

• Experiencia de al menos 1 año en CMC en Asuntos Regulatorios.
• Dominio del inglés y español.

Responsabilidades

• Gestionar dossiers específicos de productos y aplicaciones de registro.
• Responder cartas de deficiencia y coordinar respuestas.
• Soporte en el desarrollo de medicamentos escribiendo secciones CMC de IMPDs.

Conocimientos

Analytical skills

Quality-oriented skills

Customer-focused skills

Effective communication

Educación

Background in Health Sciences

Descripción del empleo

Asphalion is growing, and we are looking for a Regulatory Affairs Officer to join our CMC unit of consultants for the pharmaceutical industry ! Someone who loves taking on new challenges, working in an international environment, and wants to grow with us!

Main responsibilities :

• CMC officer, reporting to CMC Manager
• Managing product-specific dossiers (Mod. 2 / Mod. 3), registration applications, variation and renewal packages in the EU, US, and RoW markets.
• Responding to deficiency letters, including coordination and preparation of responses.
• Supporting drug development by writing CMC sections of IMPDs and INDs.
• Managing RA CMC change control assessments when required.
• Acting as RA CMC liaison with clinical, non-clinical, and other teams involved in the product lifecycle.
• Establishing and improving processes and work instructions.
• Ensuring deadlines are met with high quality to achieve client satisfaction.
• Participating as a speaker in internal and external team training sessions.

Requirements :

• At least 1 year of experience in CMC in Regulatory Affairs within the pharmaceutical industry and / or consultancy.
• Background in Health Sciences.
• Strong analytical, quality-oriented, and customer-focused skills.
• Proficiency in English and Spanish.
• Willingness to learn and take on new responsibilities.
• Good team player with effective communication skills.
• Ability to handle multiple tasks in a fast-paced environment.
• Motivated, positive, and enthusiastic attitude.

Why work at Asphalion?

• Flexible working hours - Friday until 15 : 30.
• Homeoffice & Hybrid or Remote Model (work from anywhere in Spain).
• Variety of projects, challenges, and learning opportunities.
• Training and personal development programs.
• Inclusive, high-performance environment focused on growth and well-being, built on Passion, Flexibility, Commitment, Quality & Teamwork.
• Multinational team with over 15 nationalities.
• Well-being programs supporting physical, psychological, and emotional health.

Additional information :

• Seniority level : Associate
• Employment type : Full-time
• Job function : Consulting, Science, and Project Management
• Industries : Pharmaceutical Manufacturing and Business Consulting & Services

J-18808-Ljbffr

J-18808-Ljbffr