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G556 Regulatory Affairs Officer Cmc – Biological Products Specialist

hace 4 semanas

Torrejón de Ardoz, Madrid, España Asphalion A tiempo completo

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:

Reporting to: CMC Manager

  1. Global CMC drafting / management of product specific dossiers (Mod. 2 / Mod. 3), with special focus on biological products, including new registration applications, variation packages and renewal packages in EU, US and RoW markets.
  2. Support in responses to deficiency letters, including coordination and preparation of responses to questions.
  3. CMC support during drug development, including writing CMC sections of IMPDs and INDs.
  4. RA CMC change control evaluation / management, when necessary.
  5. RA CMC liaison with clinical and non-clinical teams, RA lifecycle management teams, technical / subject matter experts, QA, QC, production and supply, as per project needs.
  6. Independent CMC project management.
  7. Successful client management of regulatory affairs.
  8. Establishment and improvement of CMC related processes and work instructions.
  9. Responsible for meeting deadlines, ensuring quality first time and maintaining customer satisfaction.
  10. Preparation and participation as a speaker in internal and external team related training sessions focused on CMC of biologics.
Requirements:
  1. +2 years' experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and / or Consultancy is required.
  2. Specializing in biological products.
  3. Background in Health Sciences, preferably biochemistry, biotechnology, biomedicine and related careers.
  4. Microsoft Office independent user level.
  5. Good analytical, quality-oriented, and customer-focused skills.
  6. High level of English and Spanish.
  7. Willing to learn and take on new challenges and responsibilities.
  8. Good team player with good communication skills.
  9. Ability to handle multiple tasks / projects in a fast-paced environment.
  10. Truckloads of motivation, positivity, and enthusiasm.
Why working at Asphalion?
  • Permanent contract.
  • Flexible working schedule - Friday until 15.30h.
  • Hybrid Model (You can work everywhere in Spain).
  • Wide variety of projects, new challenges and experiences.
  • Training and personal development program.
  • English lessons.

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