RA CMC Associate Director
vor 3 Wochen
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.
As an Associate Director, you will independently establish and drive strategic and operational global CMC regulatory direction and documentation for projects/products covering development, registration and approval/post approval activities. Make informed regulatory decisions, balancing patient and business risks and benefits leading to timely Health Authority approvals. As an experienced member of the department, facilitate consistency within the CMC regulatory documentation by providing regulatory advice within and outside the department.
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.
Apply today and welcome to where we thrive together
Major Accountabilities:
- Formulate, lead and drive 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.
- Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions.
- Initiate and lead Health Authority interactions and negotiations.
Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired.
- Minimum 8 years of regulatory CMC experience and/or pharmaceutical industry experience.
- Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Proven ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of product development and lifecycle desirable.
- Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning and prioritizing activities simultaneously on multiple projects.
- Regularly demonstrated active contributions to line functions or project teams, as well as contributions to matrix teams with the necessary strategic thinking.
- Demonstrated leadership in a matrix organization, including ability to influence global matrix teams, and provide guidance and direction to team members.
- Demonstrated ability for innovative and big picture thinking. Strong planning, negotiation, organizational and interpersonal skills.
- Computer/IT systems literacy.
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 €78,400/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.
AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Functional Area Research & Development
Job Type Full time
Employment Type Regular
Shift Work No
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