Regulatory Affairs Officer - Writing Cmc

buscojobs España; Toledo; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A multinational company is seeking a Regulatory Affairs Officer to join their CMC unit. The role involves managing product-specific dossiers and collaborating with clinical teams to ensure compliance in the pharmaceutical industry. Ideal candidates will have a background in Health Sciences and strong analytical skills, with opportunities for personal development and a supportive work environment.

Servicios

Permanent contract

Hybrid or remote work model

Training and personal development programs

Well-being programs focusing on health

Inclusive and professional environment

Formación

• At least 1 year of experience in CMC within Regulatory Affairs.
• Proficiency in English and Spanish.
• Ability to manage multiple tasks in a fast-paced environment.

Responsabilidades

• Manage and write product-specific dossiers for registration applications.
• Provide CMC support during drug development.
• Act as the RA CMC liaison with various teams.

Conocimientos

Analytical skills

Quality orientation

Customer focus

Effective communication

Team player

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! 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 the CMC Manager.
2. Manage and write product-specific dossiers (Mod. 2 / Mod. 3), new registration applications, variation packages, and renewal packages in the EU, US, and RoW markets.
3. Support responses to deficiency letters, including coordination and preparation of responses.
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 the RA CMC liaison with clinical and non-clinical teams, RA lifecycle management teams, technical/subject matter experts, QA, QC, Production, and Supply, based on project needs.
7. Maintain successful client management.
8. Establish and improve processes and work instructions.
9. Ensure deadlines are met, prioritize first-time quality, and maintain client satisfaction.
10. Participate as a speaker in team-related training sessions, both internal and external.

Requirements:

• At least 1 year of experience in CMC within Regulatory Affairs in the pharmaceutical industry or consultancy.

Background in Health Sciences.

Strong analytical skills, quality orientation, and customer focus.

Proficiency in English and Spanish.

Willingness to learn, take on new challenges, and responsibilities.

Good team player with effective communication skills.

Ability to manage multiple tasks/projects in a fast-paced environment.

Motivated, positive, and enthusiastic attitude.

Why work at Asphalion?

• Permanent contract.
• Homeoffice, hybrid, or remote work model (work anywhere in Spain).
• Variety of projects, challenges, and experiences.
• Training and personal development programs.
• Inclusive, professional, high-performance environment fostering skill development and career growth.
• Company culture centered on Passion, Flexibility, Commitment, Quality, and Camaraderie.
• Multinational team with over 15 nationalities.
• Well-being programs focusing on physical, psychological, and emotional health.
• Internal activities and RSC initiatives.
• Equal Opportunity Employer.