REGULATORY OPERATIONS AND SYSTEMS MANAGEMENT

MCR International; Madrid; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

An established industry player seeks a Junior Associate in Regulatory Operations and Systems Management. This role involves maintaining Regulatory Information Systems, ensuring compliance with international standards, and managing data integrity. You'll collaborate closely with internal teams to develop best practices and provide training on regulatory systems. The ideal candidate will have a background in Life Sciences or Computer Science, strong analytical skills, and at least two years of experience in the pharmaceutical sector. Join this dynamic team and contribute to impactful regulatory processes in a fast-paced environment!

Formación

• Minimum 2 years of experience in Regulatory Operations in the pharmaceutical industry.
• Fluent in English; knowledge of Spanish is a plus.

Responsabilidades

• Ensure systems’ information aligns with international regulatory standards.
• Participate in the management of upgrades and ensure data integrity.

Conocimientos

Analytical Skills

Problem-Solving Skills

Communication Skills

Interpersonal Skills

Self-Motivated

Educación

Bachelor’s degree in Life Sciences

Bachelor’s degree in Computer Science/Technology

Herramientas

Document Management Systems

eCTD Submission Tools

Descripción del empleo

LF-2503-124
REGULATORY OPERATIONS AND SYSTEMS MANAGEMENT
MADRID

The Junior Associate, Regulatory Operations and Systems Management, in close collaboration with the Regulatory Operations team, is responsible for the maintenance of the Regulatory Information Systems and their Data, Documents and Dossiers, which is essential for ensuring an efficient Information Flow and Regulatory Compliance.

Regulatory Systems Compliance and Management

• Ensure that all systems’ information align with international regulatory standards in the Life Sciences sector.
• Create and maintain regulatory master data in compliance with worldwide IDMP regulations and Company’s requirements.
• Participate in the management of Upgrades Releases by reviewing the features, assessing their impact on business processes, and performing informal and formal tests.
• Ensure the conformity of related Regulatory Quality Documents (Processes and Procedures) and participate in their global continuous improvement.
• Manage Systems’ Users Access.

Information Management

• Participate in the development of best practices regarding the utilization of the RIM System.
• Ensure the completion of data into the RIM System, in compliance with Countries’ Regulations.
• Target compliance to Regulatory Data integrity via regular Quality Check of the Database.
• Participate in the management of in-house Publishing activities.
• Participate in the compliance of Submitted Dossiers Storage.
• Manage the preparation of documentation to support global submissions and to support Supply Chain, QA, and Manufacturing Departments, including but not limited to Certificates of Pharmaceutical Product, Power of Attorney, applicable legalization procedures, and Approved Marketing Authorization Details.

Training and Support

• Provide guidance and expertise on Regulatory Operations to both internal and external stakeholders.
• Ensure awareness of the Users.
• Deliver regular and ad-hoc instructions and training sessions on the importance and utilization of Regulatory Systems, master data & transactional data, documents, and dossiers.

Requirements

• Education: Bachelor’s degree in Life Sciences or Computer Science / Technology (e.g., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent.
• Personal skills:
• Self-motivated and open to new challenges.
• Analytical and problem-solving skills.
• Strong communication skills.
• Strong interpersonal skills, ability to work cross-functionally and comfortably in a dynamic fast-paced environment.
• Languages: Fluent English. Knowledge of Spanish will be an asset.
• Experience: Minimum 2 years of experience in Regulatory Operations / Regulatory in the pharmaceutical industry.
• Specific Knowledge:
• Experience in the preparation, publishing, and eCTD submission for IND/CTA, BLA/MAA to regulatory agencies.
• Experience in regulatory data traceability.
• Direct hands-on experience working with document management systems, document formatting and publishing tools, eCTD validation, and viewers.
• Knowledge of EMA, FDA, and ICH regulations and guidelines on eCTD structure and specifications.