Job Description

Are you interested to learn more about Regulatory Affairs Chemistry, Manufacturing and Controls (RA CMC) and the pharmaceutical industry?

After your Master’s, Doctoral or Post-doctoral qualification, do you want a career in Regulatory Affairs CMC?

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 CMC Postgraduate Training Program is an opportunity to discover the global function of Regulatory Chemistry, Manufacturing and Controls.

Successful candidates will be offered a 2 year training position consisting of rotational assignments within different RA CMC areas (Small Molecules, Biologics and Cell & Gene Therapy) and functions (e.g. Policy, Product Optimization).

Location: Schaftenau, Austria

Duration and start of training: 2 years with an expected start date beginning January 2026

Deadline for applications: 17 August 2025

Interviews: September/October 2025

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 RA CMC Policy group analysing he Regulatory Frameworks and informing/updating the internal RA CMC community

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);
• CV and Cover letter in English required to apply;
• For your cover letter, please consider addressing the following: Articulate clearly your desire to join this particular program, your specific motivations for Regulatory Affairs CMC and how this opportunity will facilitate your future career ambitions.

• 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

Please note that we can only accept applicants who are eligible to work in Austria or are a citizen of the European Union.

Novartis is an equal opportunity employer committed to embracing and leveraging diverse backgrounds.

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 59,781.96/year (on a full-time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

Adjustments for Applicants with Disabilities:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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

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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