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- Tasks: Drive regulatory strategy and manage submissions for pharmaceutical products.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Enjoy hybrid work options, professional growth opportunities, and a supportive culture.
- Why this job: Be part of a passionate team making a real impact on patients' lives.
- Qualifications: Bachelor's or Master's in Life Sciences; experience in regulatory affairs required.
- Other info: Commitment to diversity and inclusion is at the heart of our culture.
The predicted salary is between 43200 - 72000 £ per year.
We are looking for an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is critical in driving regulatory strategy and managing operational activities across key regions. You will collaborate with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory requirements, supporting the successful development and commercialization of pharmaceutical products.
Major Responsibilities:
- Implement regional regulatory strategies in alignment with global objectives.
- Contribute to global regulatory planning and identify strategic gaps or risks.
- Lead or support Health Authority (HA) interactions, including briefing material preparation.
- Coordinate timely and compliant regulatory submissions across assigned regions.
- Review and approve Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and Risk Management Plans.
- Act as a liaison with local HAs (e.g. FDA, EMA) as required.
- Ensure timely and effective responses to HA queries and requests.
- Collaborate cross-functionally to align regulatory plans with business goals.
- Monitor and ensure compliance with internal policies and external regulations.
- Support or lead negotiations for regional approvals to meet project timelines.
Essential Requirements:
- Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
- Proven experience in regulatory affairs within the pharmaceutical industry.
- Strong understanding of drug development and clinical trial processes.
- Experience in managing regulatory submissions and HA interactions.
Commitment to Diversity and Inclusion/EEO. Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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.
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Global Regulatory Affairs Manager (Global Program Regulatory Manager) employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Affairs Manager (Global Program Regulatory Manager)
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the pharmaceutical industry in both the UK and Ireland. Understanding the nuances of local regulations will help you stand out as a candidate who is not only knowledgeable but also proactive in navigating complex regulatory landscapes.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with Health Authorities like the FDA and EMA. Engaging in conversations with industry insiders can provide valuable insights and potentially lead to referrals that could enhance your application.
✨Tip Number 3
Stay updated on the latest trends and changes in global regulatory policies by following relevant publications and attending industry conferences. Demonstrating your commitment to continuous learning can make a strong impression during interviews.
✨Tip Number 4
Prepare for potential interviews by practising responses to common questions related to regulatory strategy and compliance. Be ready to discuss specific examples from your past experiences that showcase your ability to manage submissions and interact with Health Authorities effectively.
We think you need these skills to ace Global Regulatory Affairs Manager (Global Program Regulatory Manager)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly within the pharmaceutical industry. Emphasise your understanding of drug development and clinical trial processes, as these are crucial for the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your background aligns with the responsibilities outlined in the job description. Mention specific experiences that demonstrate your ability to manage regulatory submissions and interact with health authorities.
Highlight Key Skills: Focus on key skills such as strategic planning, compliance monitoring, and cross-functional collaboration. Use examples from your past roles to illustrate how you've successfully implemented regulatory strategies or managed submissions.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any grammatical errors or typos. A polished application reflects your attention to detail, which is essential in regulatory affairs.
How to prepare for a job interview at Novartis
✨Understand Regulatory Frameworks
Familiarise yourself with the regulatory frameworks relevant to the pharmaceutical industry, especially those pertaining to the FDA and EMA. Being able to discuss these frameworks confidently will demonstrate your expertise and readiness for the role.
✨Prepare for Cross-Functional Collaboration
Since this role involves working with various teams, be ready to discuss your experience in cross-functional collaboration. Prepare examples of how you've successfully worked with different departments to achieve regulatory goals.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss specific challenges you've faced in regulatory affairs and how you overcame them. Highlighting your problem-solving skills will show that you can handle the complexities of regulatory submissions and compliance.
✨Demonstrate Your Commitment to Diversity and Inclusion
As Novartis values diversity and inclusion, think about how you can contribute to this culture. Be ready to share your thoughts on the importance of diverse teams in driving innovation and improving patient outcomes.
