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- Tasks: Manage regulatory documentation and ensure compliance with industry standards.
- Company: Join Novartis, a leader in reimagining medicine for better lives.
- Benefits: Enjoy hybrid working, competitive rewards, and a commitment to diversity.
- Why this job: Be part of a mission-driven team that makes a real impact on patients' lives.
- Qualifications: Bachelor's degree in life sciences and experience in regulatory publishing required.
- Other info: Work in a dynamic environment with opportunities for growth and collaboration.
The predicted salary is between 30000 - 42000 £ per year.
Join to apply for the Regulatory Publishing Associate role at Novartis Join to apply for the Regulatory Publishing Associate role at Novartis Get AI-powered advice on this job and more exclusive features. 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. 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 Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Marketing, Public Relations, and Writing/Editing Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Novartis by 2x Get notified about new Publisher jobs in London, England, United Kingdom . 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Regulatory Publishing Associate employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Publishing Associate
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements and documentation standards relevant to the pharmaceutical industry. Understanding the nuances of eCTD and other submission formats will give you an edge in discussions during interviews.
✨Tip Number 2
Network with professionals already working in regulatory publishing or related fields. Attend industry events or webinars to make connections that could lead to referrals or insider information about the role at Novartis.
✨Tip Number 3
Demonstrate your analytical skills by preparing examples of how you've solved complex problems in previous roles. Be ready to discuss these scenarios in detail, as they can showcase your ability to handle the responsibilities of the Regulatory Publishing Associate position.
✨Tip Number 4
Stay updated on the latest trends and changes in global regulatory requirements. Showing that you are proactive about your professional development can impress interviewers and demonstrate your commitment to the field.
We think you need these skills to ace Regulatory Publishing Associate
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Regulatory Publishing Associate role at Novartis. Understand the key responsibilities and required skills, such as experience with electronic document publishing standards and regulatory submission processes.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory publishing, project management, and any specific tools mentioned in the job description, like eCTD or Veeva. Use keywords from the job listing to ensure your application stands out.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for the pharmaceutical industry and your understanding of Novartis' mission. Mention how your skills align with their goals and how you can contribute to their success.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a role that involves managing documentation and compliance.
How to prepare for a job interview at Novartis
✨Understand Regulatory Requirements
Familiarise yourself with the key regulatory requirements relevant to the role, such as eCTD and EU CTR standards. Being able to discuss these in detail will show your preparedness and understanding of the industry.
✨Showcase Your Technical Skills
Be ready to talk about your experience with publishing tools like DXC or Veeva. Highlight specific projects where you used these tools to manage documentation or submissions, demonstrating your hands-on expertise.
✨Demonstrate Analytical Thinking
Prepare examples that showcase your analytical skills, especially in evaluating data and preparing summaries. Discuss how you've approached problem-solving in past roles, particularly in a regulatory context.
✨Emphasise Team Collaboration
Since this role involves working with cross-functional teams, be prepared to share experiences where you successfully collaborated with others. Highlight your interpersonal skills and how they contributed to project success.
