Regulatory Affairs Officer CMC - Biological products Specialist [UO515]

Asphalion; Logroño; Híbrido; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Regulatory Affairs Officer to join their dynamic CMC unit. This role offers the chance to work on global regulatory submissions and support drug development processes, particularly for biological products. You'll thrive in a hybrid work environment, collaborating with a diverse team while enhancing your skills through a comprehensive training program. If you're motivated, customer-focused, and eager to take on new challenges, this opportunity will allow you to grow in a supportive and high-performance culture.

Servicios

Permanent contract

Training and personal development program

Physical, psychological and emotional well-being programme

Inclusive work environment

Wide variety of projects

Formación

• 2 years’ experience in CMC in Regulatory Affairs in the Pharmaceutical Industry.
• Specializing in biological products with a strong analytical focus.

Responsabilidades

• Manage global CMC drafting and product-specific dossiers for biological products.
• Coordinate responses to deficiency letters and manage client relationships.

Conocimientos

Regulatory Affairs

CMC Management

Analytical Skills

Communication Skills

Team Collaboration

Educación

Health Sciences

Biochemistry

Biotechnology

Biomedicine

Descripción del empleo

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
• 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.
• Support in responses to deficiency letters, including coordination and preparation of responses to questions.
• CMC support during drug development, including writing 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.
• Successful client management of regulatory affairs.
• Establishment and improvement of CMC related processes and work instructions.
• Responsible for meeting deadlines, ensuring quality first time and maintaining customer satisfaction.
• Preparation and participation as a speaker in internal and external team related training sessions focused on CMC of biologics.

Requirements :

• 2 years’ experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and / or Consultancy is required.
• Specializing in biological products.
• Background in Health Sciences, preferably biochemistry, biotechnology, biomedicine and related careers.
• Good analytical, quality-oriented, and customer-focused skills.
• High level of English and Spanish.
• Willing to learn and take on new challenges and responsibilities.
• 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.
• Hybrid Model (You can work everywhere in Spain).
• Wide variety of projects, new challenges and experiences.
• Training and personal development program.
• 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.