Senior Manager Regulatory Affairs (d/f/m)
Senior Manager Regulatory Affairs (d/f/m)
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
Your responsibilities include, but are not limited to:
- Leading role in the following activities: evaluation of regulatory requirements, development of regulatory strategy, preparation and/or coordination of preparation of submission documents (incl. electronic submissions) after approval of initial marketing authorization (incl. variations, renewals, PSURs) as well as initial dossier submissions in designated countries
- Own the preparation of responses to regulatory relevant queries from various partners and directly interact with regulatory authorities and/or with regulatory functions in the countries
- Responsible for leading interactions with regulatory functions in the countries and where applicable, for leading the regulatory (sub)team and for representing all regulatory functions in the global project team(s)
- Identify potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations
- Provide input and collaborate with partners about implementing strategies, ensuring timelines and requirements, or assuring congruency and compliance
- Act as representative of regulatory functions in cross-functional project teams and workstreams
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
- University degree in natural sciences, ideally PhD or comparable qualification
- At least 5 years work experience in pharmaceutical or biotech regulatory affairs, knowledge in maintenance activities desirable
- Good interpersonal and communication skills
- Ability to work effectively in a matrix environment in a multi-cultural setting
- Proficient in English (oral and written)
- Strong communication, negotiation and interpersonal skills.
- Ability to work in interdisciplinary teams
- Attention to detail and quality focused
- Ability to interpret scientific data and to construct persuasive regulatory documents
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 € 60,212.18/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 are open for part-time and job sharing models and support flexible and remote working where possible.
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Tue, 10 Oct 2023 07:43:42 GMT
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