Regulatory Affairs Officer - Writing CMC

Sé de los primeros solicitantes.
Solo para miembros registrados
Santiago de Compostela
EUR 30.000 - 45.000
Sé de los primeros solicitantes.
Ayer
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.