Regulatory Affairs Officer - Writing CMC

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