Regulatory Affairs Officer - Writing CMC

ASPHALION; Sevilla; Híbrido; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

ASPHALION is seeking a Regulatory Affairs Officer for its CMC unit in a dynamic and international environment. The role involves managing product-specific regulatory filings, supporting drug development processes, and fostering client relationships while promoting a culture of growth and professional development. The position offers flexible working arrangements, career advancement opportunities, and a focus on employee well-being in a supportive company culture.

Servicios

Flexible working schedule

Homeoffice & Hybrid or Remote Model

Training and personal development program

Physical, psychological and emotional well-being programme

Formación

• 1+ years’ experience in CMC in Regulatory Affairs.
• High level of English and Spanish.
• Good analytical, quality-oriented, and customer-focused skills.

Responsabilidades

• Management of product-specific dossiers and new registration applications.
• CMC support during drug development.
• Client management and process improvement.

Conocimientos

Analytical skills

Quality-oriented

Customer-focused

Communication skills

Ability to handle multiple tasks

Motivation

Positivity

Team player

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

Main responsibilities :

• CMC officer, reporting to CMC Manager
• Overall CMC writing / management of product-specific dossiers (Mod. 2 / Mod. 3), new registration applications, variation packages and renewal packages in the EU, US and RoW markets.
• Support in responses to deficiency letters including coordination and preparation of responses to questions.
• CMC support during drug development, including writing of CMC sections of IMPDs and INDs.
• RA CMC change control assessment / management, when required.
• RA CMC liaison person with clinical and non-clinical teams, RA lifecycle management teams, tech / subject matter experts, QA, QC, Production and Supply, as per project needs.
• Successful client management.
• Establishing and improving processes and work instructions.
• Responsible for achieving deadlines, working towards first-time quality, to ensure client satisfaction.
• Preparation of and participation as a speaker on team-related training, both internal and external.

Requirements : +1 years’ experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and / or Consultancy is required. Background in Health Sciences. Microsoft Office independent user level. Good analytical, quality-oriented, and customer-focused skills. High level of English and Spanish Willing to learn and take on new challenges and responsibilities Good team player with good communication skills Ability to handle multiple tasks / projects in a fast-paced environment Truckloads of motivation, positivity, and enthusiasm.

Why working at Asphalion? ️Permanent contract. Flexible working schedule - Friday until 15.30h. Homeoffice & Hybrid or Remote Model

You can work everywhere in Spain) ️ Wide variety of projects, new challenges and experiences. ️ Training and personal development program. English lessons. A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship. A highly & dynamic working environment with employees from more than 15 nationalities. Our people and their well-being are our priority : Physical, psychological and emotional well-being programme. Internal activities & RSC Activitie Equal Opportunity Employer