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- Tasks: Drive regulatory strategy and manage submissions for pharmaceutical products.
- Company: Join Novartis, a leader in healthcare committed to diversity and inclusion.
- Benefits: Enjoy hybrid work options, professional growth opportunities, and a supportive community.
- Why this job: Be part of a team that makes a real impact on patients' lives.
- Qualifications: Bachelor's or Master's in Life Sciences; experience in regulatory affairs required.
- Other info: Work in London or Dublin, collaborating with global teams.
The predicted salary is between 43200 - 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.
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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 latest regulatory guidelines and frameworks relevant to the pharmaceutical industry. This knowledge will not only help you in interviews but also demonstrate your proactive approach to staying updated in a fast-evolving field.
✨Tip Number 2
Network with professionals in regulatory affairs, especially those who have experience with global submissions. Engaging in discussions or attending industry events can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in managing regulatory submissions and interactions with health authorities. Highlighting your achievements in these areas can set you apart from other candidates.
✨Tip Number 4
Research Novartis' recent projects and initiatives in regulatory affairs. Understanding their strategic goals and challenges will allow you to tailor your conversation during interviews, showing that you're genuinely interested in contributing to their success.
We think you need these skills to ace Global Regulatory Affairs Manager (Global Program Regulatory Manager)
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Global Regulatory Affairs Manager position. 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 in regulatory affairs within the pharmaceutical industry. Provide specific examples of how you've managed regulatory submissions and interacted with health authorities.
Showcase Your Skills: Demonstrate your understanding of drug development and clinical trial processes. Mention any relevant qualifications or certifications that align with the role's requirements, such as a degree in Life Sciences or Pharmacy.
Tailor Your Application: Customise your CV and cover letter to reflect Novartis' commitment to diversity and inclusion. Highlight any experiences that showcase your ability to work collaboratively in diverse teams, as this is an important aspect of their culture.
How to prepare for a job interview at Novartis
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulatory frameworks relevant to the pharmaceutical industry, especially those pertaining to the regions you'll be working in. Familiarise yourself with the FDA and EMA guidelines, as well as any recent changes that may impact submissions.
✨Prepare for Cross-Functional Collaboration
Since this role involves working with various teams, be ready to discuss your experience in cross-functional collaboration. Think of specific examples where you've successfully aligned regulatory plans with business goals and how you navigated challenges in those situations.
✨Showcase Your Problem-Solving Skills
Regulatory affairs often involve identifying strategic gaps or risks. Be prepared to share instances where you've proactively addressed such issues. Highlight your analytical skills and how you've contributed to successful regulatory strategies in past roles.
✨Demonstrate Your Commitment to Diversity and Inclusion
Novartis values diversity and inclusion, so be ready to discuss how you can contribute to an inclusive work environment. Share your thoughts on the importance of diverse teams in driving innovation and how you've fostered inclusivity in your previous roles.
