Asphalion is growing and we are looking for a Regulatory Affairs Consultant / Senior Consultant 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 writing 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:
* +5 years’ experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required.
* Previous experience predominantly with 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)
* 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 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