Regulatory Affairs Officer - Writing CMC

ASPHALION; Las Palmas de Gran Canaria; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading consulting firm in the pharmaceutical industry is looking for a Regulatory Affairs Officer to work in their CMC unit. The role involves managing product-specific dossiers and supporting drug development while ensuring compliance and effective client relationships. The ideal candidate will have a background in health sciences, be proficient in both English and Spanish, and demonstrate strong analytical and communication skills. This position offers flexible working arrangements, a permanent contract, and numerous opportunities for professional development.

Servicios

Flexible working schedule

Home office & hybrid or remote work model

Wide variety of projects and challenges

Training and personal development programs

Well-being programs for health

Formación

• +1 year of experience in CMC within Regulatory Affairs in the pharmaceutical industry and/or consultancy.
• High proficiency in English and Spanish.
• Motivated, positive, and enthusiastic attitude.

Responsabilidades

• Manage product-specific dossiers (Mod. 2 / Mod. 3) and registration applications in the EU, US, and RoW.
• Serve as RA CMC liaison with clinical and non-clinical teams.
• Ensure deadlines are met, maintaining first-time quality.

Conocimientos

Analytical skills

Quality-oriented

Customer-focused

Communication skills

Educación

Background in Health Sciences

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 new challenges, enjoys working in an international environment, and wants to grow with us!

Main responsibilities:

1. CMC officer, reporting to CMC Manager
2. Manage 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 control processes as required.
6. Serve as the RA CMC liaison with clinical and non-clinical teams, RA lifecycle management teams, technical/subject matter experts, QA, QC, Production, and Supply.
7. Manage client relationships effectively.
8. Establish and improve processes and work instructions.
9. Ensure deadlines are met, maintaining first-time quality to achieve client satisfaction.
10. Participate as a speaker in team-related training, both internal and external.

Requirements: +1 year of experience in CMC within Regulatory Affairs in the pharmaceutical industry and/or consultancy. Background in Health Sciences. Proficient in Microsoft Office. Strong analytical, quality-oriented, and customer-focused skills. High proficiency in English and Spanish. Willingness to learn and take on new challenges. Good team player with excellent 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
• Wide variety of projects and challenges
• Training and personal development programs, including English lessons
• Inclusive, high-performance work environment to develop your skills and grow your career
• Company culture centered on Passion, Flexibility, Commitment, Quality, and Companionship
• Multinational team with employees from over 15 nationalities
• Well-being programs for physical, psychological, and emotional health
• Internal activities & corporate social responsibility initiatives

Our commitment: We are an Equal Opportunity Employer.