342731BR
Apr 22, 2022
Switzerland

Job Description

Are you interested to learn more about Regulatory Affairs (RA) and the pharmaceutical industry?
After your Master’s, Doctoral or Post-doctoral qualification, do you want a career in Regulatory Affairs?
Do you have a collaborative mindset and take ownership of assigned tasks? Are you able to quickly adapt to different teams and concepts, with excellent problem solving skills?
Would you like to work and gain experience in a cross-functional team in the multicultural and diverse environment of a leading global healthcare company?
The Regulatory Affairs Postgraduate Training Program is an opportunity to discover the global functions of Regulatory Affairs and Regulatory Chemistry, Manufacturing and Controls.
Successful candidates will be offered a training position consisting of two rotational assignments, each of 1-year duration, within two different RA functions.

Responsibilities could include, but are not limited to:
• Interacting with global interdisciplinary project teams to provide strategic regulatory input to development, submission planning, documentation needed, as well as timelines and strategic risks
• Supporting and/or preparing high quality dossiers, drug substance and/or drug product quality documentation to support global regulatory submissions (e.g. Clinical Trial Applications, Market Authorization Applications, post-approval variations etc.)
• Supporting and/or preparing high quality dossiers according to specific requirements in the different countries and regions
• Supporting submission and response activities (planning, preparation, review, coordination, submission)
• Ensuring regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submission of variations and participation in the change control process
• Supporting the development and maintenance of globally consistent product information
• Supporting the Regulatory Intelligence group analysing the EU Regulatory Framework and informing the internal RA community
• Monitoring, searching for and evaluating legislation, as well as guidelines from different sources

Duration and start of training: 2 years with an expected start date beginning January 2023
Deadline for applications: 31 May 2022
Interviews: September 2022


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Minimum requirements:

• Strong interest in Regulatory Affairs and Drug Development;
• Completion of an MSc, PhD, PharmD or Post-doctoral qualification in Pharmaceutical Sciences/Pharmacy/Life Sciences or equivalent and/or in Regulatory Affairs (desirable) within the last 24 months;
• Fluency in English (written and spoken);
• Ready to expand your knowledge and are open minded with an international outlook
• Strong interpersonal skills i.e. can demonstrate your ability to communicate well with people from a variety of backgrounds/cultures and at different hierarchical levels inside and outside the company
• CV and Cover letter in English required to apply;
For your cover letter, please consider addressing the following: articulate clearly in your cover letter your desire to join this particular program, your specific motivations for regulatory affairs and how this opportunity will facilitate your future career ambitions in Regulatory Affairs


Why Novartis? 799 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Global Drug Development
REG AFFAIRS GDD
Switzerland
Basel
Interns/Students on Novartis Payroll
Full Time
Internship
No
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342731BR

RA Postgraduate Intern

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