Regulatory Affairs Officer - Writing CMC

ASPHALION; Andosilla; A distancia; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

Asphalion, a growing consultancy in the pharmaceutical industry, is seeking a Regulatory Affairs Officer for their CMC unit. The role involves managing product dossiers for registrations and interaction with various teams to ensure compliance and client satisfaction. Candidates should possess strong analytical skills, a background in health sciences, and be team-oriented with effective communication skills. Opportunities for training and personal development are available, alongside a flexible working model.

Servicios

Permanent contract

Homeoffice & Hybrid or Remote Model

Training and personal development program

Formación

• 1 year of experience in CMC in Regulatory Affairs.
• High level of English and Spanish.
• Ability to handle multiple tasks in a fast-paced environment.

Responsabilidades

• Manage product-specific dossiers (Mod. 2 / Mod. 3) and new registration applications.
• Liaison with clinical teams and regulatory lifecycle management.
• Prepare and present team-related training.

Conocimientos

Analytical skills

Quality-oriented

Customer-focused

Communication skills

Team player

Educación

Background in Health Sciences

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 :

• CMC officer, reporting to CMC Manager
• Overall CMC writing / management of product-specific dossiers (Mod. 2 / Mod. 3), new registration applications, variation packages and renewal packages in the 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 of CMC sections of IMPDs and INDs.
• RA CMC change control assessment / management, when required.
• RA CMC liaison person with clinical and non-clinical teams, RA lifecycle management teams, tech / subject matter experts, QA, QC, Production and Supply, as per project needs.
• Successful client management.
• Establishing and improving processes and work instructions.
• Responsible for achieving deadlines, working towards first-time quality, to ensure client satisfaction.
• Preparation of and participation as a speaker on team-related training, both internal and external.

Requirements :

• 1 years’ experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and / or Consultancy is required.
• Background in Health Sciences.
• 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.

Homeoffice & Hybrid or Remote Model (You can work everywhere in Spain)

Wide variety of projects, new challenges and experiences.

Training and personal development program.

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