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

Main responsibilities:

1. CMC officer, reporting to CMC Manager
2. Overall CMC writing and management of product-specific dossiers (Mod. 2 / Mod. 3), 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. Support during drug development, including writing of CMC sections of IMPDs and INDs.
5. RA CMC change control assessment and management, when 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, as per project needs.
7. Manage CMC projects independently.
8. Ensure successful client management.
9. Establish and improve processes and work instructions.
10. Meet deadlines, work towards first-time quality, and ensure client satisfaction.
11. Participate as a speaker in team-related training, both internal and external.

Requirements:

• At least 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.
• Proficiency in English and Spanish.
• Willing to learn and take on new challenges and responsibilities.
• Good team player with effective 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, including Fridays until 15:30.
• Home office, hybrid, or remote work options (work anywhere in Spain).
• Variety of projects, challenges, and experiences.
• Training and personal development programs.
• 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 from over 15 nationalities.
• Focus on employee well-being: physical, psychological, and emotional programs.
• Internal activities and CSR initiatives.

Note: This job posting is active and not expired.