Regulatory Affairs Officer - Writing CMC

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