Regulatory Affairs Officer - Writing CMC

ASPHALION; Oviedo; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

ASPHALION is seeking a Regulatory Affairs Officer to join their CMC unit. The role involves managing product-specific dossiers in international markets, supporting drug development, and collaborating with various teams. This position offers a permanent contract with flexible working options, training programs, and a supportive work culture focused on employee well-being.

Servicios

Flexible working hours

Home office options

Training and personal development programs

Employee well-being programs

Formación

• At least 1 year of experience in CMC within Regulatory Affairs in the pharmaceutical industry.
• High proficiency in English and Spanish.
• Good team player with strong communication skills.

Responsabilidades

• Manage product-specific dossiers and new registration applications in various markets.
• Provide CMC support during drug development, including writing sections for IMPDs and INDs.
• Establish and improve processes and ensure deadlines are met.

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 the 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 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, depending on project needs.
7. Manage client relationships successfully.
8. Establish and improve processes and work instructions.
9. Ensure deadlines are met, maintain first-time quality, and achieve 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.
• 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 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 with flexible working hours - Friday until 15:30.
• Home office, hybrid, or remote work options.
• Work from anywhere in Spain.
• Variety of projects, new challenges, and experiences.
• Training and personal development programs, including English lessons.
• Inclusive, high-performance work environment fostering skill development and career growth.
• Company culture centered on Passion, Flexibility, Commitment, Quality, and Camaraderie.
• International team with over 15 nationalities.
• Employee well-being programs, including physical, psychological, and emotional support.
• Internal activities and CSR initiatives.

We are an Equal Opportunity Employer.