Regulatory Affairs Officer CMC – Biological products Specialist - Italy

Asphalion is growing and we are looking for a Regulatory Affairs Senior 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:

• Global CMC writing/management of product specific dossiers (Mod. 2/Mod. 3), with special focus on biologics (including ATMPs and Biosimilars), for new registration applications and variation packages mainly in EU and US markets.
• Support in responses to deficiency letters, including coordination and preparation of responses.
• CMC support during drug development, including roadmaps, gap analysis and writing of CMC sections of IMPDs and INDs.
• RA CMC change control evaluation/management, when necessary.
• 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.
• Independent CMC project management.
• Successful client management of regulatory affairs.
• Establishment and improvement of CMC related processes and work instructions.
• Responsible for meeting deadlines, ensuring first time quality and maintaining customer satisfaction.
• Preparation and participation as a speaker in internal and external team related training sessions focused on CMC of biologics.

Requirements:

• +4 years’ experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required.
• Specializing in biological products
• Background in Biosciences or Health Sciences.
• Microsoft Office independent user level.
• Good analytical, quality-oriented, and customer-focused skills.
• High level of English (C1) and Spanish (B2)
• 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.

Remote Model (You can work everywhere in Italy)

⚙️ Wide variety of projects, new challenges and experiences.

↗️ Training and personal development program.

English lessons.