Regulatory Affairs Officer CMC - Biological products Specialist

Location: Gasteiz / Vitoria

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:
+3 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
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.
Hybrid 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 Activities
✅ Equal Opportunity Employer