RA Postgraduate Intern
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 a start date beginning January 2025
Deadline for applications: 7 June 2024
Interviews: starting June 2024 (virtual) to September 2024 (face-to-face in Basel)
Minimum requirements:
- Strong interest in Regulatory Affairs and Drug Development;
- Completion of a 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);
- CV and Cover letter in English; For your cover letter, please consider addressing the following: Articulate clearly 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
- 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
Novartis is an equal opportunity employer committed to embrace and leverage diverse backgrounds.
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(link is external)
Division Development Business Unit Pharmaceuticals Location Switzerland Site Basel (City) Company / Legal Entity C028 (FCRS = CH028) Novartis Pharma AG Job Type Full time Employment Type Early Talent (Fixed Term) Shift Work No Apply to Job(link is external)
