Job Description Summary
The Regulatory Affairs CMC Postgraduate Training Program in Schaftenau, Austria, offers an opportunity to explore the global function of Regulatory Chemistry, Manufacturing, and Controls.
Successful candidates will receive a 2-year training position with rotational assignments across various RA CMC areas (Small Molecules, Biologics, and Cell & Gene Therapy) and functions (e.g., Policy, Product Optimization).
Job Description
Are you interested in learning more about Regulatory Affairs Chemistry, Manufacturing, and Controls (RA CMC) and the pharmaceutical industry?
After completing your Master’s, Doctoral, or Post-doctoral qualification, are you seeking a career in Regulatory Affairs CMC?
Do you possess a collaborative mindset, take ownership of tasks, and adapt quickly to different teams and concepts with excellent problem-solving skills?
Would you like to work in a multicultural, diverse environment within a leading global healthcare company?
The Regulatory Affairs CMC Postgraduate Training Program provides an opportunity to understand the global role of Regulatory Chemistry, Manufacturing, and Controls.
Successful candidates will undertake a 2-year training program with rotational assignments in different RA CMC areas and functions.
Location: Schaftenau, Austria
Duration and start: 2 years, beginning January 2026
Application deadline: 17 August 2025
Interviews: September/October 2025
Responsibilities may include, but are not limited to:
* Collaborating with global interdisciplinary project teams to provide strategic regulatory input for development, submission planning, documentation, timelines, and risk assessment
* Supporting or preparing high-quality dossiers and documentation for global regulatory submissions (e.g., Clinical Trial Applications, Market Authorization Applications, post-approval variations)
* Preparing dossiers tailored to specific country and regional requirements
* Supporting submission activities, including planning, review, and coordination
* Ensuring regulatory compliance by understanding requirements and guidelines, facilitating timely variations, and participating in change control processes
* Assisting in the development and maintenance of consistent global product information
* Analyzing regulatory frameworks and updating the RA CMC community through the Policy group
Minimum requirements:
* Strong interest in Regulatory Affairs and Drug Development
* Recent completion (within 24 months) of MSc, PhD, PharmD, or Post-doctoral qualification in Pharmaceutical Sciences, Pharmacy, Life Sciences, or Regulatory Affairs (desirable)
* Fluency in English (written and spoken)
* CV and cover letter in English; cover letter should express your motivation, specific interest in the program, and how it aligns with your career goals
* Eligible to work in Austria or an EU citizen
We can only consider applicants eligible to work in Austria or who are EU citizens.
Novartis is an equal opportunity employer committed to diversity.
We offer a competitive salary, incentive programs, pension scheme, childcare facilities, learning opportunities, and global career prospects. The minimum salary according to Austrian law is €59,781.96/year for full-time employment, with potential for additional compensation based on experience and qualifications.
Commitment to Diversity & Inclusion:
We are dedicated to fostering an inclusive work environment and diverse teams that reflect the communities we serve.
Adjustments for Applicants with Disabilities:
If you require accommodations during the recruitment process due to a medical condition, disability, or neurodiversity, please contact disabilities.austria@novartis.com. We will provide guidance and support throughout the process.
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