At a Glance
- Tasks: Support regulatory operations and ensure timely submissions for clinical trials and approvals.
- Company: Join Novartis, a leader in reimagining medicine with a commitment to diversity.
- Benefits: Competitive salary, performance bonuses, flexible working, and comprehensive wellbeing resources.
- Other info: Enjoy a hybrid work model and excellent career development opportunities.
- Why this job: Make a real impact in healthcare while growing your career in a dynamic environment.
- Qualifications: Experience in pharmaceuticals and regulatory compliance, with strong collaboration skills.
The predicted salary is between 32690 - 60710 £ per year.
This role is based in London, UK. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.
The Regulatory Senior Coordinator (Sr RC) works under the supervision of the respective regulatory affairs (RA) program teams and/or team lead. The Sr RC provides advanced high quality and timely operational regulatory and compliance support on assigned programs and/or activities through development, registration, and post approval phases.
Major accountabilities:
- Provide operational regulatory support for a portfolio of programs.
- Independently coordinate with other groups within RA to finalise and ensure timely dispatch of Health Authority submissions as aligned with assigned program RA sub-teams.
- Contribute to or lead preparation of assigned Module 1 documents including forms and cover letters with oversight of the RA program lead(s).
- Support RA sub-team for clinical trial related activities (CTA forms and tracking, transfer of obligations submissions, drug shipment ticket review, etc.).
- Independently manage assigned regulatory compliance and maintenance activities for clinical trial, registration and post-approval regulatory activities.
- Ensure tracking and update of relevant regulatory information in Novartis compliance systems and trackers as provided by RA sub-team representatives.
- May act as super-user and/or subject matter expert for selected topics or systems.
Minimum Requirements:
- Pharmaceutical experience. Regulatory experience preferred.
- Prior publishing/Regulatory Operations experience preferred.
- Good collaboration and communication skills.
- Fast and flexible, focused on timely delivery and stretch targets.
- Ability to plan and prioritize workload.
- Compliance and quality mindset.
Benefits & Rewards:
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
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, Collaboration, Detail-Oriented, Project Planning, Regulatory Compliance
Senior RA Coordinator in London employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid work model allows for flexibility while providing ample opportunities for professional growth and development in the pharmaceutical industry. With a commitment to enhancing customer experiences for healthcare professionals and patients alike, joining our team means contributing to meaningful work that makes a difference in people's lives.
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We think this is how you could land Senior RA Coordinator in London
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We think you need these skills to ace Senior RA Coordinator in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Novartis!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Novartis that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Novartis
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Novartis that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
