Regulatory Drug Substance Manager (d/f/m)
Your responsibilities include, but are not limited to:
- Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance
- 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 global regulatory strategies, current regulatory trends and guidelines.
What you’ll bring to the role:
- Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent with oral and written fluency in English.
- Ideally, at least 2 years’ experience in regulatory and/or in the pharmaceutical industry; 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.
- Good written and spoken English skills with German nice to have
- Structured and organized way of working
- Ability to learn and willingness to develop further
- Ability to critically evaluate data from a broad range of scientific disciplines.
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. 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). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We support flexible and remote working within Austria where possible.
Commitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Job search | Sandoz
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