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- Tasks: Drive global regulatory strategies and execute registration plans for international markets.
- Company: Join Novartis, a leading inclusive employer committed to diversity and community impact.
- Benefits: Enjoy hybrid work options, professional growth opportunities, and a supportive team culture.
- Why this job: Be part of a mission-driven team that changes lives through innovative science and collaboration.
- Qualifications: Experience in regulatory affairs, project management, and a strong team-oriented mindset required.
- Other info: This role is based in London with a focus on international regulatory challenges.
The predicted salary is between 28800 - 43200 £ per year.
Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary #LI-Hybrid (3 days per week on-site)
Location: London (The Westworks), United Kingdom
Internal Job Title: International Program Regulatory Manager (IPRM)
Are you passionate about driving global regulatory strategies and ensuring timely execution of registration plans? As an IPRM, you'll collaborate closely with international regulatory teams and global functions to support product registrations across diverse international markets. You'll play a key role in maintaining regulatory intelligence, enhancing operational efficiency, and contributing to cross-functional initiatives-all while working under the guidance of the International Program Regulatory Director. About the Role
Key responsibilities:
- Providing input into registration strategies for INT countries and drives the execution of registration plans as defined in the INT RA subteam and in partnership with the countries, regional roles and global line functions as applicable including procurement of ancillary documents for submission dossier, contribution to responses to Health Authority (HA) questions, follow up on key milestone activities by relevant RA and line function stakeholders.
- Supporting the IPRD in partnering with DU RA roles to obtain, digest and communicate efficiently pipeline information to relevant stakeholders.
- Ensures updates to registration plans are performed timely and with the necessary quality.
- Supporting the IPRD in the execution of plans for Emerging Markets Brands for assigned projects.
- Assisting the IPRD in the execution of registration plans for products that target diseases which are predominantly prevalent in INT countries.
- Partnering the IPRD in the execution of geographic expansion plans for INT countries.
- Driving the dissemination of information to and education of global roles on INT country/regional requirements.
- Advancing the implementation of functional or cross-functional initiatives, particularly those with potential impacts on INT RA resources or FTE allocations.
Essential Requirements:
- Experience in Regulatory affairs in a country, regional or global regulatory setting.
- Experience in regulatory license maintenance and new product registrations
- Ability to work in cross-functional environment.
- Experience in project management.
- Highly committed and team oriented.
- Ability to recognize potential regulatory issues, complex situations, sound risk assessment and overcoming hurdles.
- Strong team player.
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.
Why Novartis: 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. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
#LI-DNI
International Regulatory Affairs Manager (International Program Regulatory Manager) employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land International Regulatory Affairs Manager (International Program Regulatory Manager)
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks of the countries you’ll be working with. Understanding local regulations and compliance requirements can set you apart from other candidates.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in international markets. Engaging with industry groups or attending relevant conferences can provide valuable insights and connections.
✨Tip Number 3
Demonstrate your project management skills by discussing any relevant experiences where you successfully led cross-functional teams. Highlighting your ability to manage complex projects will resonate well with the hiring team.
✨Tip Number 4
Show your commitment to diversity and inclusion in your conversations. Novartis values these principles, so sharing your experiences or initiatives that promote inclusivity can strengthen your application.
We think you need these skills to ace International Regulatory Affairs Manager (International Program Regulatory Manager)
Some tips for your application 🫡
Understand the Role: Take time to thoroughly read the job description for the International Regulatory Affairs Manager position. Understand the key responsibilities and essential requirements, as this will help you tailor your application to highlight relevant experiences.
Tailor Your CV: Customise your CV to reflect your experience in regulatory affairs, project management, and cross-functional collaboration. Use specific examples that demonstrate your ability to handle regulatory issues and your commitment to diversity and inclusion.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for the role and the company. Mention how your values align with Novartis' commitment to diversity and inclusion, and how you can contribute to their mission.
Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. Ensure that your writing is clear and professional, as attention to detail is crucial in regulatory affairs.
How to prepare for a job interview at Novartis
✨Understand Regulatory Frameworks
Familiarise yourself with the regulatory frameworks relevant to international markets. Be prepared to discuss how these frameworks impact product registration and compliance, as this will demonstrate your expertise in the field.
✨Showcase Project Management Skills
Highlight your experience in project management during the interview. Discuss specific projects where you successfully managed timelines and collaborated with cross-functional teams, as this role requires strong organisational skills.
✨Emphasise Team Collaboration
Since the role involves working closely with various teams, be ready to share examples of how you've effectively collaborated in a team environment. This will show that you are a strong team player, which is essential for success in this position.
✨Prepare for Scenario-Based Questions
Anticipate scenario-based questions that assess your problem-solving abilities in regulatory affairs. Think of past experiences where you identified regulatory issues and how you overcame them, as this will showcase your critical thinking skills.
