Regulatory Affairs Officer Cmc - Biological Products Specialist

buscojobs España; Guadalajara; Híbrido; USD 30,000 - 45,000; Jornada completa

Descripción de la vacante

A growing company is seeking a Regulatory Affairs Officer to join their CMC unit. The role involves managing documentation and supporting drug development in a dynamic, international environment. Candidates should have experience in CMC regulatory affairs, particularly with biological products, and be proficient in English and Spanish.

Servicios

Permanent contract

Hybrid work model

Training and personal development programs

Formación

• At least 2 years of experience in CMC regulatory affairs.
• Specialization in biological products, ideally in plasma.

Responsabilidades

• Managing global CMC documentation and product-specific dossiers.
• Providing CMC support during drug development.
• Managing client relationships in regulatory affairs.

Conocimientos

Analytical Skills

Customer Orientation

Teamwork

Communication Skills

Proficiency in English

Proficiency in Spanish

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! We seek someone who loves new challenges, enjoys working in an international environment, and wants to grow with us.

Main responsibilities :

1. Reporting to: CMC Manager
2. Managing global CMC documentation, including drafting and managing product-specific dossiers (Mod. 2 / Mod. 3), with a focus on biological products, including registration applications, variation, and renewal packages in EU, US, and RoW markets.
3. Supporting responses to deficiency letters, including coordinating and preparing responses to questions.
4. Providing CMC support during drug development, including writing CMC sections of IMPDs and INDs.
5. Evaluating and managing RA CMC change control processes when necessary.
6. Collaborating with clinical, non-clinical, and other relevant teams, including RA lifecycle management, technical experts, QA, QC, production, and supply, based on project needs.
7. Managing client relationships in regulatory affairs effectively.
8. Establishing and improving CMC-related processes and work instructions.
9. Ensuring timely delivery of tasks, maintaining quality, and customer satisfaction.
10. Participating as a speaker in internal and external training sessions focused on CMC of biologics.

Requirements :

1. At least 2 years of experience in CMC regulatory affairs within the pharmaceutical industry or consultancy.
2. Specialization in biological products, ideally in plasma.
3. Background in health sciences, such as biochemistry, biotechnology, biomedicine, or related fields.
4. Strong analytical skills, quality focus, and customer orientation.
5. Proficiency in English and Spanish.
6. Willingness to learn and take on new challenges and responsibilities.
7. Good teamwork and communication skills.
8. Ability to manage multiple tasks in a fast-paced environment.
9. Motivated, positive, and enthusiastic attitude.

Why work at Asphalion?

• Permanent contract.
• Hybrid work model (work from anywhere in Spain).
• Variety of projects, challenges, and experiences.
• Training and personal development programs.