At a Glance
- Tasks: Drive regulatory strategy and manage submissions for pharmaceutical products.
- Company: Join a leading global pharmaceutical company committed to diversity and inclusion.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with excellent career advancement opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while collaborating with diverse teams.
- Qualifications: Bachelor’s or Master’s in Life Sciences and experience in regulatory affairs.
The predicted salary is between 36000 - 60000 € per year.
Overview
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
Global Regulatory Affairs Manager (Global Program Regulatory Manager) in City of London employer: Healthcare Businesswomen’s Association
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work environment in the heart of London or Dublin. Our commitment to employee growth is reflected in our robust training programmes and opportunities for cross-functional collaboration, ensuring that you can thrive in your role as a Global Regulatory Affairs Manager. With a focus on diversity and innovation, we empower our teams to make a meaningful impact in the pharmaceutical industry while enjoying a flexible hybrid work model.
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) in City of London
✨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 scenarios related to HA interactions, so you’re ready to impress!
✨Tip Number 3
Showcase your experience with regulatory submissions and clinical trials during interviews. We want to hear about your successes and how you’ve navigated challenges in the past—this is your chance to shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our company.
We think you need these skills to ace Global Regulatory Affairs Manager (Global Program Regulatory Manager) in City of London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Global Regulatory Affairs Manager role. Highlight your experience in regulatory affairs and any relevant skills that match the job description. We want to see how your background aligns 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 specific experiences that demonstrate your expertise in managing regulatory submissions.
Showcase Your Collaboration Skills:Since this role involves working with cross-functional teams, make sure to highlight your collaboration skills in your application. Share examples of how you've successfully worked with others to achieve regulatory goals in the past.
Apply Through Our Website:We encourage you to apply through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to the right people. Don’t miss out on this opportunity!
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨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 expertise and readiness for 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 successfully navigated complex 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 strategies 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 it’s the right fit for you.
