Regulatory Affairs Officer - Writing CMC

ASPHALION; Valladolid; Híbrido; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

ASPHALION, une entreprise dynamique dans le secteur pharmaceutique, recherche un Regulatory Affairs Officer pour rejoindre son équipe CMC. Vous serez responsable de la gestion de dossiers d'inscription et du soutien dans le développement de médicaments. L'entreprise offre un contrat permanent, un environnement de travail flexible et des opportunités de développement personnel au sein d'une équipe internationale.

Servicios

Contrat permanent

Horaires flexibles - Vendredi jusqu'à 15:30

Modèle de télétravail et hybride

Variété de projets et défis

Programmes de formation et de développement personnel

Environnement inclusif et performant

Programmes de bien-être

Formación

• Plus d'un an d'expérience en CMC dans les affaires réglementaires.
• Maîtrise de l'anglais et de l'espagnol.
• Bonne capacité à gérer plusieurs projets dans un environnement dynamique.

Responsabilidades

• Gérer les dossiers spécifiques aux produits pour les marchés EU, US et RoW.
• Assurer la liaison entre équipes réglementaires, cliniques et techniques.
• Participer à des sessions de formation internes et externes.

Conocimientos

Compétences analytiques

Orientation qualité

Axé sur le client

Travail en équipe

Communication

Educación

Formation en sciences de la santé

Herramientas

Microsoft Office

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. We seek someone who loves to take on new challenges, work in an international environment, and grow with us!

Main responsibilities:

1. CMC officer, reporting to CMC Manager
2. Manage product-specific dossiers (Mod. 2 / Mod. 3), including writing and management of new registration applications, variation packages, and renewal packages in the EU, US, and RoW markets.
3. Support in responses to deficiency letters, including coordination and preparation of responses to questions.
4. Provide CMC support during drug development, including writing CMC sections of IMPDs and INDs.
5. Assess and manage RA CMC change controls as required.
6. Act as RA CMC liaison with clinical and non-clinical teams, RA lifecycle management teams, technical/subject matter experts, QA, QC, Production, and Supply, according to project needs.
7. Manage client relationships successfully.
8. Establish and improve processes and work instructions.
9. Ensure deadlines are met, maintaining first-time quality to ensure client satisfaction.
10. Participate as a speaker in team-related training sessions, both internal and external.

Requirements: +1 year of experience in CMC in Regulatory Affairs within the pharmaceutical industry and/or consultancy. Background in Health Sciences. Proficient in Microsoft Office. Good analytical, quality-oriented, and customer-focused skills. High proficiency in English and Spanish. Willing to learn and take on new challenges and responsibilities. Good team player with strong communication skills. Ability to handle multiple tasks/projects in a fast-paced environment. Motivated, positive, and enthusiastic attitude.

Why work at Asphalion?

• Permanent contract
• Flexible working schedule - Fridays until 15:30
• Home office & hybrid or remote work model
• Work from anywhere in Spain
• Variety of projects, new challenges, and experiences
• Training and personal development programs, including English lessons
• Inclusive, high-performance environment to develop your skills and grow your career
• Company culture centered around Passion, Flexibility, Commitment, Quality, and Camaraderie
• International team with over 15 nationalities
• Well-being programs addressing physical, psychological, and emotional health
• Internal activities & RSC initiatives
• Equal Opportunity Employer