Job Description Summary
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. We are optimizing and strengthening our processes and ways of working, investing in new technologies, and building specific therapeutic area and platform depth and capabilities to bring our medicines to patients faster. We are seeking key talent to help give people with disease and their families a brighter future. As a manager, you provide strategic and operational global CMC regulatory direction and documentation for our products covering development and post-approval activities. You bring regulatory knowledge regarding drug development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mindset.
Major accountabilities
* Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Biologics and Small Molecules projects/products.
* Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
* Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
* Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
* Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
* Prepare and communicate CMC risk management assessments and lessons learned on major submissions.
* Initiate and lead Health Authority interactions and negotiations.
Minimum Requirements
* Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired.
* Ideally, at least 2 years’ experience in regulatory CMC experience and/or pharmaceutical industry experience; working knowledge in regulatory submissions desirable.
* Demonstrated working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
* Ability to critically evaluate data from a broad range of scientific disciplines.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us. Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive
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 €63,600/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work 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 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.
Join our Novartis Network
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Change Control, Cross-Functional Teams, Documentation Management, Negotiation Skills, Regulatory Compliance, Risk Assessment, Risk Management, Waterfall Model
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