Regulatory Affairs Graduate & Postgraduate Program. Novartis Pharma AG Novartis Animal Health AG

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1 Regulatory Affairs Graduate Postgraduate Program Novartis Pharma AG Novartis Animal Health AG

2 The Regulatory Affairs (RA) Graduate Program is an opportunity to discover the global functions of Drug Regulatory Affairs (DRA) and Regulatory Chemistry, Manufacturing and Controls (REG CMC). The most successful candidates will be offered a Regulatory Affairs Postgraduate Program, consisting of rotation assignments within these departments. The Regulatory Affairs Graduate Program at Novartis Pharma provides the possibility to gain an insight into the pharmaceutical industry, learn more about career opportunities within Regulatory Affairs at Novartis and experience our diverse and modern work environment at the Novartis Campus in Basel, Switzerland. Thanks to this Program, we can now source a good part of open positions with "internally grown" talents. Gesa Pellier DRA Region Head EU, China The Regulatory Affairs Postgraduate Program will enable you to expand your regulatory knowledge, getting familiarized with dossier content and acquire a significant practical experience through cross-functional projects in different areas in a dynamic environment to build on your future career at Novartis. Diane Zezza Global Head Regulatory CMC Our Regulatory Affairs Postgraduate Program is a unique opportunity to elaborate on a strong foundation in Regulatory Affairs to build your future career. It will not only enable you to transfer your theoretical know-how into practice but also to grow your internal network by working on different assignments and rotating through different areas of Regulatory Affairs. The Regulatory Affairs Graduate Program at Novartis Animal Health will provide an overview of the RD and life cycle management processes. It is a unique opportunity to work with different species and to develop knowledge about veterinary specific dosage forms (e. g. medicated premixes, chewable tablets) and regulations. Robert Kowalski Global Head DRA Stephen Martin Head Global Regulatory Affairs (NAH)

3 Mission of Drug Regulatory Affairs (DRA) and Regulatory Chemistry, Manufacturing and Controls (REG CMC) DRA aims to secure industry best approval times with commercially attractive labeling and ensures compliance with company policy, national regulations and laws through development, registration and approval/post-approval phase. DRA also aims to provide strategic input and tactical support for global development projects and product life-cycle management. In Pharma, the DRA organisation is structured around Global Franchises (such as Primary Care, Critical Care, Integrated Hospital Care, Neuroscience and Ophthalmics, Oncology and Established Medicines), Regional Regulatory Strategy and Excellence Groups (Regions Europe incl. EU Liaison and Policy, US and AGL (large group of other International countries), and Global Expert Groups representing the backbone of all regional and Franchise activities, such as Global Labeling, DRA Operations and Quality Procedures and Compliance. REG CMC aims to provide regulatory strategic input to enhance the quality of technical activities and produce high quality regulatory CMC dossiers for both pre- and post-approval submissions. REG CMC also supports the regulatory requirements for formulation, scale-up, product launch and site transfer activities throughout the product lifecycle from concept to commercialization and divestment. REG CMC operates in collaboration with DRA across all therapeutic areas focusing on operational excellence and flexibility to create superior value for our customers. Regulatory Affairs has an impact on business via efficient support of competitive new product registrations, maintenance and regulatory compliance.

4 Activities covered by DRA and /or REG CMC: Interact globally with interdisciplinary project teams to bring strategic regulatory input, plan submission strategy, communicate source documents needed as well as timelines and strategic risks Prepare high quality dossiers, drug substance and/or drug product quality documentation to support global regulatory submissions (e. g. Clinical Trial applications, MAA Applications, post-approval variations, etc.) Prepare high quality dossiers according to specific requirements in the different countries (e. g. USA, EU, LATAM, Japan, etc) For veterinary products, prepare Maximum Residue Limit (MRL) application for food producing animals Lead submission and responses activities (planning, preparation, review, coordination, submission) as key Health Authority (HA) contact Ensure regulatory compliance by creating awareness of requirements and guidelines, facilitating timely variations submissions and participation in the change control operations Develop and globally maintain consistent product information Lead Intelligence Networks and influence draft regulatory requirements and guidelines Monitor, search for and evaluate legislation as well as guidelines from different sources. Prepare adequate training documentation.

5 Program concept REGULATORY AFFAIRS GRADUATE PROGRAM REGULATORY AFFAIRS POSTGRADUATE PROGRAM Welcome Appraisal Training Appraisal Training Day Training Target Career setting optional Target optional Target Discussion rotation setting rotation setting RA Graduate Program Are you interested to learn more about the pharmaceutical industry and Regulatory Affairs? Are you currently enrolled in a Life Sciences and/or Regulatory Affairs Masters Study and seeking an internship position to complete your degree? Would you like to experience work in a multicultural and diverse environment of a global healthcare company? Then the RA Graduate Program (of generally 6 months) in the global headquarters of Novartis Pharma AG or Novartis Animal Health AG Basel, Switzerland, offers the right opportunity for you. It will help you to develop your career path in a way that meets your personal aspirations. RA Postgraduate Program The RA Postgraduate Program will be offered to the most successful candidates of the RA Graduate Program. This 18 months Program will enable you to grow professionally and gain practical experience by rotating through different groups, tailored to your profile. It will provide a solid foundation for your future career in RA.

6 Qualification and requirements How to apply To apply please access the Novartis Career website at and follow the Link Training positions in Switzerland and submit online for the respective Job ID. You are recognized for your skills in your field in the last stage of your Master studies in Sciences (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, Veterinary Medicine) or equivalent and Regulatory Affairs. RA Graduate / Postgraduate Program Strong interest in Regulatory Affairs and Drug Development Master studies in Life Sciences or equivalent and in Drug Regulatory Affairs (desirable) Fluency in English; additional languages, e. g. German or French are welcome 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 hierarchy levels inside outside the company Novartis is an equal opportunity employer committed to embracing and leveraging diverse backgrounds.

7 Comments from successful Postgraduates and current intern I joined the Novartis Animal Health Regulatory Affairs Department in March 2013 and in a short period of time I quickly widened my knowledge in terms of veterinary regulation. I acquired a strong practical experience as well, by supporting my colleagues in many daily tasks such as supporting dossier creation for international markets, submitting a variation, preparing the administrative part of a dossier for the submission of a brand new product. The small size of this department offers a real chance to get more responsibility and it greatly improves the communication between people! The continuous support of the team and the various activities make me say that this internship fully meets my personal aspirations Anissa Meddah, DRA intern (Joined Novartis in March 2013) Thanks to this Regulatory Affairs Graduate and Post-Graduate Program, I could rotate in four different groups (2 Business Franchises: Respiratory and Cardiovascular Metabolism, Global Regulatory CMC and DRA Global Labelling). In those groups I could work on a variety of regulatory activities covering the whole drug lifecycle and including Reg CMC tasks. The knowledge and the network acquired help me a lot now in my current GPRM rolejob. Fiona Benali-Winter, GPRM in the Oncology Business Unit (Joined Novartis as DRA intern in 2011) My experience as an Intern first and, thereafter, as a Postgraduate, has served as a strong foundation for the start of my career. Besides the large number of regulatory activities I had the chance to work on, I have also had the opportunity to discover the drug development process from the inside. During this program, I have specifically appreciated the interactions with the numerous line functions and the various opportunities of trainings and networking events. As a cherry on the cake, the Novartis Campus in Basel is a true example of an inspiring and stimulating workplace. Caroline Baumann, GPRM in the Oncology Business Unit (Joined Novartis as DRA intern in 2011) The Regulatory Affairs Graduate and Post-graduate Program was the perfect opportunity to discover several groups in the Drug Regulatory Affairs department and to get an overview of the various regulatory activities that DRA managers are handling every day. During this program, I have been working in the Regulatory Intelligence group and in two Business Franchises (Neuroscience and Established Medicines). I was involved in several activities such as clinical trial applications, regulatory intelligence activities, submissions of variations, as well as some US activities. This program allowed me to confirm that regulatory affairs is the field in which I want to work. Last but not least, I did find a GPRM position during my last rotation. Amandine Roemer, Global Program Regulatory Manager in EM (DRA intern/postgraduate in 2010/2011) The Regulatory Affairs Graduate and Postgraduate Programs gave me the opportunity to apply and strengthen the knowledge acquired during my studies. I worked in different groups within the Regulatory Affairs department (Global Labeling; and two Business Franchises, Ophthalmology and Integrated Hospital Care) where I could expand my regulatory expertise and acquire a practical experience on development and post-marketing activities, such as clinical trials, type II variations for the registration of a new indication, core data sheet updates and divestments; practical experience that I can now apply in my day to day work as GPRM. These programs are thus a very good opportunity to build and start a promising career within the challenging and dynamic environment of the pharmaceutical industry. Gaëlle Enderlin, GPRM in the IHC Business Franchise (Joined Novartis as DRA intern in 2011) Training positions in Switzerland

8 Novartis Pharma AG Pharma Basel Operations HR University Relations CH-4056 Basel Switzerland Contact For more information, please visit

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