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- Tasks: Drive regulatory strategy and manage submissions for pharmaceutical products.
- Company: Join a leading pharmaceutical company committed to diversity and inclusion.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in global healthcare by ensuring compliance and successful product launches.
- Qualifications: Degree in Life Sciences or Pharmacy and experience in regulatory affairs.
- Other info: Collaborative environment with a focus on innovation and career development.
The predicted salary is between 60000 - 84000 £ per year.
Overview
Job Description Summary
#LI-Hybrid (12 days per month on-site) — Location: London (The Westworks), United Kingdom or Dublin, Ireland. Internal Job Title: Global Program Regulatory Manager. 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.
Skills Desired
Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance
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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
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory strategies and compliance. We recommend practising common interview questions and having examples ready that showcase your experience in managing submissions and HA interactions.
✨Tip Number 3
Don’t just apply anywhere—focus on companies that align with your values and career goals. We suggest checking out our website for openings that match your skills and interests, especially in the pharmaceutical sector.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe it’s a great way to keep you top of mind for hiring managers.
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 is tailored to the Global Regulatory Affairs Manager role. Highlight your relevant experience in regulatory affairs and any specific achievements that align with the job description. We want to see how your background fits with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our team. Be sure to mention any specific experiences that relate to the responsibilities listed in the job description.
Showcase Your Skills: Don’t forget to highlight your skills that are essential for this role, like your understanding of drug development and clinical trial processes. We’re looking for someone who can manage regulatory submissions effectively, so make sure to showcase those abilities!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Novartis
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to the pharmaceutical industry. Familiarise yourself with the specific requirements of health authorities like the FDA and EMA, as this will show your depth of knowledge and commitment to the role.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think about past experiences where you've successfully navigated regulatory submissions or interactions with health authorities, and be ready to share those stories.
✨Show Your Collaborative Spirit
This role involves working with cross-functional teams, so be prepared to discuss how you've effectively collaborated in the past. Highlight any experiences where you aligned regulatory plans with business goals, as this will demonstrate your ability to work well with others.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the company’s approach to regulatory strategy or how they handle compliance challenges. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.