Regulatory Affairs Officer - CMC

ASPHALION; Santander; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

Asphalion is seeking a dedicated Regulatory Affairs Officer to enhance its CMC unit. This role involves managing regulatory submissions and supporting drug development, requiring a Health Sciences background and CMC experience. The successful candidate will thrive in a flexible, multicultural environment with numerous growth and learning opportunities.

Servicios

Flexible working hours

Homeoffice & Hybrid or Remote Model

Training and personal development programs

Well-being programs supporting health

Formación

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

Responsabilidades

• Managing product-specific dossiers for registration applications in various markets.
• Supporting drug development by writing CMC sections of IMPDs and INDs.
• Establishing and improving processes and work instructions.

Conocimientos

Analytical skills

Quality-oriented

Customer-focused

Effective communication

Educación

Background in Health Sciences

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 ! Someone who loves taking on new challenges, working in an international environment, and wants to grow with us!

Main responsibilities :

• CMC officer, reporting to CMC Manager
• Managing product-specific dossiers (Mod. 2 / Mod. 3), registration applications, variation and renewal packages in the EU, US, and RoW markets.
• Responding to deficiency letters, including coordination and preparation of responses.
• Supporting drug development by writing CMC sections of IMPDs and INDs.
• Managing RA CMC change control assessments when required.
• Acting as RA CMC liaison with clinical, non-clinical, and other teams involved in the product lifecycle.
• Establishing and improving processes and work instructions.
• Ensuring deadlines are met with high quality to achieve client satisfaction.
• Participating as a speaker in internal and external team training sessions.

Requirements :

• At least 1 year of experience in CMC in Regulatory Affairs within the pharmaceutical industry and / or consultancy.
• Background in Health Sciences.
• Strong analytical, quality-oriented, and customer-focused skills.
• Proficiency in English and Spanish.
• Willingness to learn and take on new responsibilities.
• Good team player with effective communication skills.
• Ability to handle multiple tasks in a fast-paced environment.
• Motivated, positive, and enthusiastic attitude.

Why work at Asphalion?

• Flexible working hours - Friday until 15 : 30.
• Homeoffice & Hybrid or Remote Model (work from anywhere in Spain).
• Variety of projects, challenges, and learning opportunities.
• Training and personal development programs.
• Inclusive, high-performance environment focused on growth and well-being, built on Passion, Flexibility, Commitment, Quality & Teamwork.
• Multinational team with over 15 nationalities.
• Well-being programs supporting physical, psychological, and emotional health.

Additional information :

• Seniority level : Associate
• Employment type : Full-time
• Job function : Consulting, Science, and Project Management
• Industries : Pharmaceutical Manufacturing and Business Consulting & Services

J-18808-Ljbffr

J-18808-Ljbffr