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- Tasks: Lead global regulatory submissions and manage cross-functional teams to ensure timely delivery.
- Company: Join a dynamic organization focused on innovative drug development and regulatory excellence.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Be at the forefront of global health regulations and make a real impact in the industry.
- Qualifications: Bachelor's degree in life sciences; experience in regulatory affairs and project management required.
- Other info: Familiarity with global HA regulations and strong problem-solving skills are essential.
The predicted salary is between 43200 - 72000 £ per year.
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Lead and manage multiple and simultaneous global regulatory submissions in eCTD and non-eCTD formats components.
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Drive cross-functional teams focused on the planning, overseeing compilation activities, and dispatch of worldwide regulatory HA submissions, anticipating technical obstacles and developing solutions.
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Negotiate timelines, manage global stakeholder expectations, publishing team and leadership communications.
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Provide guidance to global project teams on worldwide HA submission format/requirements, filing strategy, eCTD document lifecycle management and submission compilation workflows.
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Plan, manage and track delivery of submission components, coordinate submission publishing activities with publishing team, organize submission review and approvals.
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Partner across multiple cross functional functions, troubleshoot submission technical/quality issues and manage the efficient use of global resources.
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Organize, lead and participate in internal and external stakeholder meetings (including acquisitions, partnerships, and divestiture efforts).
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Develop and implement solutions to create efficiencies and effectiveness.
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Bachelor’s degree in life sciences or relevant discipline.
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Regulatory affairs or regulatory submissions related experience in global HA regulatory formats and submissions publishing activities.
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Familiarity with the drug development process, global HA regulations/guidance e.g., FDA, ICH, EMA, MENA, CH.
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Strong interpersonal, project, and time management skills and experience managing through complexities in a fast-paced, global cross functional organization.
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Effectively works as part of a team environment or independently.
Strong project management skills:
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Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
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Decisive, solution-oriented, pragmatic, customer focused, readily adapts to changing priorities and composed under pressure.
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Demonstrated negotiation skills and a positive attitude.
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Working knowledge of publishing tools (e.g., DXC (eCTDxpress/Publisher), Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tool.
Global Regulatory Submission Manager employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Submission Manager
✨Tip Number 1
Familiarize yourself with the specific global regulatory submission processes and tools mentioned in the job description, such as eCTD formats and publishing tools like DXC and Veeva. This knowledge will not only help you understand the role better but also demonstrate your commitment and readiness to hit the ground running.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with global health authorities like FDA and EMA. Engaging in conversations with them can provide valuable insights and potentially lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss your project management experiences in detail during interviews. Highlight specific examples where you've successfully managed complex projects, negotiated timelines, or resolved technical issues, as these skills are crucial for the role.
✨Tip Number 4
Stay updated on the latest trends and changes in global regulatory requirements and guidance. Being knowledgeable about current regulations will not only enhance your expertise but also show potential employers that you are proactive and dedicated to continuous learning.
We think you need these skills to ace Global Regulatory Submission Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Global Regulatory Submission Manager position. Highlight key responsibilities and required skills that align with your experience.
Tailor Your CV: Customize your CV to emphasize relevant regulatory affairs experience, particularly in global HA submission formats. Include specific examples of past projects where you managed submissions or led cross-functional teams.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the drug development process and your familiarity with global HA regulations. Mention your problem-solving skills and how you've successfully navigated complexities in previous roles.
Highlight Technical Skills: In your application, be sure to mention your proficiency with publishing tools and document management systems relevant to the role. This will demonstrate your readiness to handle the technical aspects of the position.
How to prepare for a job interview at Novartis
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of global health authority regulations and submission formats. Be prepared to discuss specific experiences where you successfully navigated regulatory requirements, as this will demonstrate your expertise in the field.
✨Demonstrate Project Management Skills
Since the role requires strong project management abilities, come prepared with examples of how you've managed multiple projects simultaneously. Discuss your approach to prioritizing tasks and managing timelines, especially in a fast-paced environment.
✨Highlight Cross-Functional Collaboration
This position involves working with various teams, so be ready to share instances where you've effectively collaborated across functions. Emphasize your communication skills and how you’ve resolved conflicts or negotiated timelines with stakeholders.
✨Prepare for Problem-Solving Scenarios
Expect questions that assess your analytical thinking and problem-solving skills. Prepare to discuss specific challenges you've faced in regulatory submissions and how you developed solutions, showcasing your ability to adapt under pressure.
