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 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.