Regulatory Affairs Officer - Writing CMC

ASPHALION; Jaén; Híbrido; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

Asphalion, a growing company in the pharmaceutical sector, seeks a Regulatory Affairs Officer to join their CMC unit. This role involves managing regulatory submissions, working in an international environment, and engaging in training and process improvement initiatives. Candidates should possess a strong background in health sciences, be bilingual in English and Spanish, and thrive in fast-paced settings.

Servicios

Permanent contract

Homeoffice & Hybrid or Remote Model

Training and personal development program

Formación

• 1 year experience in CMC Regulatory Affairs in the Pharmaceutical Industry.
• High level of English and Spanish required.
• Ability to handle multiple tasks and projects in a fast-paced environment.

Responsabilidades

• Writing and managing product-specific dossiers for regulatory submissions.
• Supporting responses to deficiency letters.
• Acting as liaison between various teams and ensuring project deadlines.

Conocimientos

Analytical skills

Quality-oriented

Customer-focused

Communication skills

Team player

Project management

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 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.
• 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.

Homeoffice & Hybrid or Remote Model (You can work everywhere in Spain)

Wide variety of projects, new challenges and experiences.

Training and personal development program.