Associate Regulatory Affairs Manager
vor 6 Monaten
About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About This Job:
In this position, you and the Regulatory Affairs Lead prepare, submit, and conduct appropriate follow-up of new Marketing for the assigned products. You will ensure that development or maintenance activities to be performed in the context of approved business activities are performed on time and in compliance with applicable regulatory demands (legislation and guidelines) throughout the product’s life cycle. For the assigned products you will ensure high-quality labeling translation and compliant printed packaging materials of marketed products and stay updated on relevant local regulations and guidelines.
Essential Job Responsibilities:
- Support the implementation locally of new initiatives, management tools or processes in cooperation with other RA functions or cross-functional
- Ensure timely and documented training and execute the development plan in alignment with the line manager
- Contribute to the local RA regulatory strategy wherever possible and needed and communicate the affiliate input to the regional RA team
- Submit, in time and with high quality, new marketing authorizations and related regulatory submissions to the concerned national competent authorities and follow up until approval has been obtained
- Communicate approvals of regulatory submission to the right stakeholders in the right way and with the right timing. Stakeholders include, but are not limited to internal and external databases, repositories, and trackers
Essential Knowledge & Experience:
- Former experience in the pharmaceutical industry is preferable, open to graduates
- Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills
- Great attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work
- Proficiency in German and understanding of another local language (French/Italian) and good written and verbal skills in English
Preferred Knowledge & Experience:
- Previous experience in Regulatory Affairs is a plus
Educations/Qualifications:
- MS Degree in Pharmacy or other Life Science (Uni/FH) or equivalent
Additional information:
- This is a permanent full-time position
- Position based in Wallisellen, Switzerland
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
**Job Type**: 100%
Work Location: In person
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