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- Tasks: Manage global regulatory submission projects and ensure compliance with documentation standards.
- Company: Join Novartis, a leading inclusive employer dedicated to improving lives through innovative medicine.
- Benefits: Enjoy hybrid working, competitive rewards, and a commitment to diversity and inclusion.
- Why this job: Be part of a mission-driven team that values collaboration and innovation in healthcare.
- Qualifications: Bachelor's degree in life sciences and experience in regulatory submission publishing required.
- Other info: Work in a dynamic environment with opportunities for personal and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to 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, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. About the Role
This role offers hybrid working, requiring 3 days per week in person in our White City, London office. Ad-hoc working hours to overlap the US as required.
Major accountabilities:
- Manages medium to small level global regulatory submission projects.
- Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
- Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
- Frequent internal company and external contacts.
- Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Minimum Requirements:
- Bachelor's degree in life sciences or relevant discipline.
- Fluency in English
- Clinical Report and Global Submission dossier publishing/compilation experience in the pharmaceutical or related industry.
- Experience with electronic clinical document publishing standards/formats, electronic and global regulatory submission publishing standards/formats (e.g. eCTD, EU CTR).
- Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools
- Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA)
- Strong interpersonal and project management skills, and experience working in a complex, global cross functional organization.
- Highly motivated, organized, and detailed oriented team player
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Publishing Associate
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements and standards mentioned in the job description, such as eCTD and EU CTR. This knowledge will not only help you understand the role better but also demonstrate your commitment and expertise during discussions.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience in regulatory publishing. Engaging with them can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss your project management skills and experiences in a global context. Highlight any relevant projects you've managed that required collaboration across different teams or regions, as this is crucial for the role.
✨Tip Number 4
Stay updated on the latest trends and changes in global regulatory requirements. Being knowledgeable about current events in the pharmaceutical industry can give you an edge in conversations and interviews.
We think you need these skills to ace Global Regulatory Publishing Associate
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Global Regulatory Publishing Associate position. Tailor your application to highlight relevant experiences that align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with clinical report publishing, regulatory submission standards, and any familiarity with tools like eCTD or Veeva. Use specific examples to demonstrate your skills and achievements in these areas.
Craft a Strong Cover Letter: Your cover letter should not only express your interest in the role but also explain how your background makes you a suitable candidate. Mention your analytical skills and project management experience, as these are key for this position.
Proofread Your Application: Ensure that your application is free from grammatical errors and typos. A well-presented application reflects your attention to detail, which is crucial for the role. Consider asking a friend or using a proofreading tool to review your documents before submission.
How to prepare for a job interview at Novartis
✨Understand Regulatory Standards
Familiarise yourself with the key regulatory standards and guidelines relevant to the pharmaceutical industry, such as eCTD and EU CTR. Being able to discuss these in detail will show your preparedness and understanding of the role.
✨Showcase Your Technical Skills
Be ready to talk about your experience with publishing tools like DXC, eCTD Xpress, or Veeva. Highlight specific projects where you successfully used these tools to manage documentation or submissions.
✨Demonstrate Project Management Experience
Prepare examples of how you've managed projects in a cross-functional environment. Discuss your approach to problem-solving and adapting to changing priorities, as these skills are crucial for the role.
✨Emphasise Interpersonal Skills
Since the role involves frequent internal and external communication, be prepared to discuss how you build relationships and collaborate with diverse teams. Share examples that illustrate your strong interpersonal skills.
