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.
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:
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.