Regulatory Submission Readiness Manager

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.; Barcelona; Hybrid; EUR 46,000 - 86,000; Full time

Benefits offered by this job

Hybrid working options

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Job summary

Novartis in Barcelona, Spain, seeks a Submission Readiness Document Manager to ensure clinical documents are submission-ready and compliant with regulatory requirements. You will coordinate cross-functional teams worldwide, drive process improvements, and strengthen document management systems and standards in a fast-paced environment.

The role requires a life sciences degree and 3–5 years in clinical development or operations, with expertise in regulatory documentation, data integrity, and

Qualifications

• Bachelor's degree in life sciences, healthcare, pharmacy, or information management.
• 3-5 years in clinical development, clinical operations, or similar environment.
• Strong expertise in clinical document management processes and regulatory requirements.
• Knowledge of documentation best practices, data integrity, and good documentation principles.
• Experience with document management systems and cross-functional global projects.

Responsibilities

• Manage submission-readiness of clinical documents for regulatory submissions.
• Oversee technical editorial and formatting of documents for submissions.
• Ensure documents meet Health Authority guidelines and GCP standards.
• Support implementation of submission-readiness strategies and templates.
• Collaborate with cross-functional teams to deliver high-quality documents on time.
• Monitor vendor performance and drive continuous improvement in processes.

Skills

Budget Management

Clinical Trials

Process Improvements

Project Planning

Vendor Management

Waterfall Model

Education

Bachelor's degree in life sciences, healthcare, pharmacy, or information management

Job description

Novartis in Barcelona, Spain, seeks a Submission Readiness Document Manager to ensure clinical documents are submission-ready and compliant with regulatory requirements. You will coordinate cross-functional teams worldwide, drive process improvements, and strengthen document management systems and standards in a fast-paced environment.

The role requires a life sciences degree and 3–5 years in clinical development or operations, with expertise in regulatory documentation, data integrity, and