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- Tasks: Lead global regulatory strategies and submissions for neuroscience programs.
- Company: Join Novartis, a diverse employer dedicated to innovative healthcare solutions.
- Benefits: Enjoy hybrid working, competitive rewards, and a supportive community.
- Why this job: Make a real impact on patients' lives while collaborating with passionate professionals.
- Qualifications: Science-based degree required; experience in regulatory processes preferred.
- Other info: Work hybrid in London, with opportunities for growth and networking.
The predicted salary is between 48000 - 72000 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Summary
As Global Program Regulatory Manager, you will work with the support of a RA Program Lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). The Global Program Regulatory Manager is also a member of the Regulatory Affairs sub team and may lead or represent RA in regional or cross functional teams.
About the Role
Key Responsibilities:
- Regulatory Strategy
- Provide input to global program regulatory strategy, including regulatory designations and innovative approaches.
- Coordinates regulatory readiness with other line functions, Country Organizations and Regions, representing Regulatory Affairs (RA) or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables.
- Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for Health Authority (HA) interactions.
- Regulatory Submissions
- Leads planning, preparation and submission of clinical trials.
- Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
- Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned.
- Lead regulatory activities during HA reviews, responding to questions and HA interactions.
- Regulatory Excellence & Compliance
- Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.
Essential Requirements:
- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.
- Experience with regulatory submission and approval processes in 1 or more major regions.
- Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
- Experience in HA negotiations.
- 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:
- Innovation in regulatory strategy.
- Understanding of post-marketing/brand optimization strategies and commercial awareness preferred.
- Involvement in dossier submissions and approvals | HA negotiations | Drug regulatory submission and commercialization in region.
- Analysis and interpretation efficacy and safety data.
- Regulatory operational expertise.
Location: UK, London Hybrid working requirement 3 days / 12 days per month in office.
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?
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.
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally.
Global Program Regulatory Manager (Neuroscience) employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Program Regulatory Manager (Neuroscience)
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and frameworks in neuroscience. Understanding the nuances of regulatory submissions in this field will give you an edge during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with Novartis or similar companies. Engaging in conversations can provide insights into the company culture and expectations.
✨Tip Number 3
Prepare to discuss your experience with cross-functional teams and how you've contributed to regulatory strategies in previous roles. Be ready to share specific examples that highlight your problem-solving skills.
✨Tip Number 4
Stay updated on recent developments in drug approval processes and HA negotiations. Being knowledgeable about current trends will demonstrate your commitment and passion for the role during discussions.
We think you need these skills to ace Global Program Regulatory Manager (Neuroscience)
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Global Program Regulatory Manager position at Novartis. Make sure you understand the key responsibilities and essential requirements, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with regulatory submissions and approvals, particularly in major regions. Mention any specific projects or roles that align with the responsibilities outlined in the job description.
Showcase Your Skills: Demonstrate your strong interpersonal, communication, negotiation, and problem-solving skills in your application. Use specific examples from your past experiences to illustrate how you've successfully navigated similar challenges.
Tailor Your Application: Customise your CV and cover letter to reflect the language and priorities of Novartis. Use keywords from the job description to ensure your application resonates with the hiring team and highlights your fit for the role.
How to prepare for a job interview at Novartis
✨Understand the Regulatory Landscape
Familiarise yourself with the current regulatory environment in neuroscience. Be prepared to discuss recent changes and how they might impact Novartis' strategies. This shows your proactive approach and genuine interest in the field.
✨Highlight Cross-Functional Experience
Since the role involves working with various teams, emphasise any experience you have in cross-functional collaboration. Share specific examples of how you've successfully navigated different departments to achieve a common goal.
✨Prepare for HA Interaction Scenarios
Anticipate questions about your experience with Health Authority interactions. Prepare to discuss specific instances where you led negotiations or addressed queries effectively, showcasing your communication and problem-solving skills.
✨Showcase Your Strategic Thinking
Be ready to discuss how you would contribute to the global regulatory strategy. Think about innovative approaches you've used in the past and how they could apply to the role at Novartis. This will demonstrate your strategic mindset and readiness to add value.
