Regulatory Affairs Senior Officer CMC – Biological products Specialist

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 :

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