Global Regulatory Publishing Associate

Novartis Farmacéutica; London; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

A forward-thinking company is seeking a dedicated regulatory submission specialist to manage global projects and ensure compliance with regulatory standards. This role offers a hybrid working environment, allowing flexibility while maintaining essential in-office collaboration. The ideal candidate will possess a strong background in life sciences, with expertise in clinical report publishing and global submission dossier compilation. Join a mission-driven team committed to improving lives through innovative medicine, and contribute to the development of global products in a dynamic, inclusive workplace.

Qualifications

• Experience in clinical report and global submission dossier publishing.
• Knowledge of electronic clinical document publishing standards.

Responsibilities

• Manage global regulatory submission projects and provide submission support.
• Represent the organization on specific projects requiring analysis.

Skills

Clinical report publishing

Global submission dossier compilation

Project management

Analytical thinking

Interpersonal skills

Education

Bachelor's degree in life sciences

Tools

eCTD

DXC

Veeva

Job description

Ensures a controlled documentation system, record retention, and information services, including electronic records retention processes in accordance with regulatory requirements. Ensures compliance with the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets & enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards, and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, and prepare information abstracts and executive summaries of searched material. Maintains extensive knowledge of product information and maintains continuous contacts with local, regional, and divisional customers.

About the Role

This role offers hybrid working, requiring 3 days per week in our White City, London office. Ad-hoc working hours to overlap with the US as required.

Major accountabilities:

• Manage medium to small-level global regulatory submission projects.
• Provide submission support and contribute to the technical regulatory strategy, intelligence, and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical support to drive implementation of global systems, tools, and processes for development projects and marketed products.
• Maintain frequent internal and external contacts.
• Represent the organization on specific projects, working on problems of moderate scope requiring analysis of various factors.
• Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt. Distribute marketing samples where applicable.

Qualifications:

• Bachelor's degree in life sciences or relevant discipline.
• Fluency in English.
• Experience with clinical report and global submission dossier publishing/compilation in the pharmaceutical industry.
• Experience with electronic clinical document publishing standards and formats (e.g., eCTD, EU CTR).
• Knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), validation tools, Document Management systems, and global submission gateways.
• Familiarity with global Clinical and Regulatory requirements (e.g., FDA, ICH, EMA, MENA, CH, MHRA).
• Strong interpersonal and project management skills, with experience in a global, cross-functional organization.
• Highly motivated, organized, detail-oriented team player.
• Analytical thinker with excellent problem-solving skills and adaptability to changing priorities.

Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives. Join us to be part of this mission. Learn more: https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion: We are dedicated to building an inclusive, diverse work environment reflective of the communities we serve.

Join our Novartis Network: Stay connected and learn about career opportunities by joining the Novartis Network: https://talentnetwork.novartis.com/network