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For Companies At a Glance
- Tasks: Shape regulatory strategy and oversee operations for pharmaceutical products.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Enjoy hybrid work options, growth opportunities, and a commitment to diversity.
- Why this job: Make a real impact on global health while collaborating with passionate teams.
- Qualifications: Bachelor’s or Master’s in Life Sciences; experience in regulatory affairs required.
- Other info: Work in London or Dublin, with a focus on compliance and innovation.
The predicted salary is between 43200 - 72000 £ per year.
We are seeking an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is essential in shaping regulatory strategy and overseeing operational activities across key regions. You will work with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory standards, supporting the development and commercialization of pharmaceutical products.
Major Responsibilities:
- Implement regional regulatory strategies aligned with global objectives.
- Contribute to global regulatory planning, identifying strategic gaps or risks.
- Lead or support interactions with Health Authorities (HAs), including preparing briefing materials.
- 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 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 managing regulatory submissions and HA interactions.
Commitment to Diversity and Inclusion/EEO
Novartis is dedicated to building an inclusive and diverse work environment that reflects the communities we serve.
Why Novartis:
Helping people with disease and their families requires more than science. It takes a community of passionate, innovative individuals like you. Join us in creating breakthroughs that change lives.
Learn more about our culture.
Join our Novartis Network: Stay connected and learn about future opportunities by signing up to our talent community.
Benefits and Rewards: Discover how we support your growth.
Global Regulatory Affairs Manager (Global Program Regulatory Manager) employer: Healthcare Businesswomen’s Association
Contact Detail:
Healthcare Businesswomen’s Association 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 relevant to the regions you’ll be working in, such as the FDA and EMA. Understanding their processes and requirements will help you demonstrate your expertise during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with global submissions. Engaging with industry groups or attending relevant conferences can provide valuable insights and connections that may benefit your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed regulatory submissions or interactions with health authorities in the past. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and changes in regulatory affairs by following industry news and publications. This knowledge will not only enhance your understanding but also show your commitment to the field during discussions with our team.
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 well as any specific interactions with Health Authorities.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Discuss how your background aligns with the responsibilities listed in the job description, such as implementing regulatory strategies and managing submissions.
Showcase Your Achievements: In both your CV and cover letter, include specific examples of past achievements in regulatory affairs. Highlight any successful submissions or interactions with Health Authorities that demonstrate your capability in this field.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Understand Regulatory Frameworks
Familiarise yourself with the regulatory frameworks relevant to the pharmaceutical industry, especially those pertaining to the regions you will be working in. This knowledge will help you demonstrate your expertise and ability to navigate complex regulatory environments.
✨Prepare for Health Authority Interactions
Since the role involves liaising with Health Authorities, practice articulating your thoughts clearly and confidently. Prepare examples of past interactions and how you successfully managed submissions or addressed queries from authorities.
✨Showcase Cross-Functional Collaboration
Be ready to discuss your experience working with cross-functional teams. Highlight specific projects where you collaborated with other departments to align regulatory strategies with business goals, showcasing your teamwork and communication skills.
✨Demonstrate Problem-Solving Skills
Regulatory affairs often involve identifying strategic gaps or risks. Prepare to discuss situations where you proactively identified issues and implemented solutions, demonstrating your critical thinking and problem-solving abilities.
