Regulatory Affairs Officer - Writing Cmc

Regulatory Affairs Officer - Writing CMC

EUR 35.000 - 55.000

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:

• CMC officer, reporting to the CMC Manager.
• Manage and write product-specific dossiers (Mod. 2 / Mod. 3), new registration applications, variation packages, and renewal packages across the EU, US, and RoW markets.
• Support responses to deficiency letters, including coordinating and preparing responses to questions.
• Provide CMC support during drug development, including writing CMC sections of IMPDs and INDs.
• Assess and manage RA CMC change control processes as required.
• 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, depending on project needs.
• Manage client relationships successfully.
• Establish and improve processes and work instructions.
• Ensure deadlines are met, prioritize first-time quality, and maintain client satisfaction.
• Participate as a speaker in team-related internal and external training sessions.

Requirements: At least 1 year of experience in CMC within Regulatory Affairs in the pharmaceutical industry and/or consultancy. Background in Health Sciences. Proficiency in Microsoft Office. Good 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 strong communication skills. Ability to handle multiple tasks/projects in a fast-paced environment. Motivated, positive, and enthusiastic.

Why work at Asphalion?

• Permanent contract.
• Home office & hybrid or remote working model.
• Work from anywhere in Spain.
• Variety of projects, challenges, and experiences.
• 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 Camaraderie.
• International team with over 15 nationalities.
• Well-being programs covering physical, psychological, and emotional health.
• Internal activities & CSR initiatives.

Note: This job posting is active and accepting applications.