Du übernimmst die Verantwortung für die globale CMC-Regulierungsstrategie und leitest die Einreichungsaktivitäten für verschiedene Projekte. In deiner Rolle kommunizierst du proaktiv über Risiken und koordinierst die Zusammenarbeit mit den Gesundheitsbehörden.
Anforderungen
- •Science degree in relevant field
- •Advanced degree desired
- •At least 2 years in regulatory CMC
- •Working knowledge of regulatory submissions
- •Knowledge of chemistry/biotechnology
- •Experience with regulations and guidelines
- •Ability to evaluate data critically
Deine Aufgaben
- •Formuliere und leite die globale CMC-Regulierungsstrategie
- •Leite und implementiere globale CMC-Einreichungsaktivitäten
- •Identifiziere erforderliche Dokumentation und zeitliche Probleme
- •Verfasse und überprüfe hochwertige CMC-Dokumentation
- •Kommuniziere proaktiv CMC-Regulierungsstrategien und Risiken
- •Bereite CMC-Risikomanagementbewertungen vor
- •Initiere und leite Interaktionen mit Gesundheitsbehörden
Deine Vorteile
Marktgerechtes Grundgehalt
Attraktives Incentive-Programm
Modernes Betriebsrentenmodell
Betreuungsangebote
Lern- und Entwicklungsmöglichkeiten
Weltweite Karrieremöglichkeiten
Mindestgehalt von 64 023,54 €/Jahr
Original Beschreibung
# Regulatory Affairs CMC Manager
**Schaftenau** | **Full time**
**Band**
Level 4
**Job Description Summary**
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
As 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.
**Job Description**
**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!
**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 € 64 023,54 /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.
**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 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.
**Skills Desired**
Change Control, Cross-Functional Teams, Documentation Management, Negotiation Skills, Regulatory Compliance, Risk Assessment, Risk Management, Waterfall Model