Regulatory Affairs Officer - Writing Cmc

buscojobs España; Badajoz; Híbrido; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

Asphalion, une entreprise en pleine croissance, recherche un Regulatory Affairs Officer pour rejoindre son équipe CMC. Le rôle implique la gestion CMC des dossiers d'enregistrement et la liaison avec diverses équipes. Profitez d'un environnement de travail flexible avec des opportunités de formation et de développement personnel. Une belle opportunité pour un candidat motivé et enthousiaste !

Servicios

Contrat permanent

Horaires de travail flexibles

Modèle de travail à domicile et hybride

Programme de formation et de développement personnel

Leçons d'anglais

Environnement de travail professionnel et inclusif

Programme de bien-être physique, psychologique et émotionnel

Formación

• Expérience de 1 an en CMC dans les affaires réglementaires.
• Anglais et espagnol requis à un niveau élevé.
• Capacité à travailler sous pression et à gérer plusieurs projets.

Responsabilidades

• Gestion CMC des dossiers spécifiques aux produits et nouvelles demandes d'enregistrement.
• Gestion de projet CMC indépendante et gestion des clients.
• Préparation et participation à la formation liée à l'équipe.

Conocimientos

Compétences analytiques

Orientation qualité

Orientation client

Compétences en communication

Educación

Formation en sciences de la santé

Herramientas

Microsoft Office

Descripción del empleo

Asphalion is growing and we are looking for aRegulatory 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. - Independent CMC project management. - 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 SpanishWilling to learn and take on new challenges and responsibilitiesGood team player with good communication skillsAbility to handle multiple tasks / projects in a fast-paced environmentTruckloads 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

Regulatory Officer • Badajoz, Kingdom Of Spain, ES