Regulatory Affairs Officer - Writing Cmc

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