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Valuing People. Science. Life - At Labatec Pharma, we are committed to deliver medicines that help to improve quality of life for patients around the world by meeting the needs of the hospital and retail sectors. We collaborate all together to deliver outcomes which add significant value to our clients' projects and the community as a whole. Our people are at the center of Labatec Pharma.
Labatec is looking for talented individuals to join its growing team Join us
Role scope
As the Regulatory Affairs Officer, you will play a pivotal role in managing regulatory activities related to product submissions and approvals in Switzerland. Additionally, you will be responsible for developing regulatory strategies for CMC. You will contribute to the team's day-to-day operations and development.
Your key responsibilities
- Regulatory Submissions Management: Lead and coordinate the preparation and submission of applications for marketing authorizations in Switzerland. Manage the maintenance of existing marketing authorizations for assigned products, including handling indication or text changes, technical modifications, commitments, and renewals. Provide support for applications, variations, and renewals in export (MENA) markets, collaborating closely with the local team.
- Regulatory Strategy Development: Develop regulatory strategies for CMC changes, product acquisitions, and due diligence activities. Perform regulatory assessments and manage any resulting regulatory actions in response to change control requests.
- Regulatory Knowledge Management: Stay abreast of CH and EU pharmaceutical regulations, ensuring compliance and alignment with evolving regulatory requirements. Develop and maintain internal regulatory SOPs, databases, and IT tools to streamline regulatory processes.
- Cross-Functional Collaboration: Collaborate with other departments, including Medical Information and Pharmacovigilance, to support regulatory activities and ensure regulatory compliance across the organization. Provide support for the review and approval of promotional materials in Switzerland, as needed.
We are looking for
- Master's degree in pharmacy or equivalent Life Science
- Minimum of 5 years of relevant experience in the EU or CH regulatory pharmaceutical environment
- Experience in CMC and Labelling
- Experience in preparation and submission of eCTD (e-publishing and e-submission system)
- Fluent in English (verbal and written). French is a strong asset.
We will offer you
- A collaborative and friendly environment within a human-size company
- An established Company operating with agility
- Continuous professional training to develop your potential
- A rewarding compensation & benefits package
About us
Labatec is a Swiss-based private pharmaceutical company, headquartered in Geneva, Switzerland. Our company has 60+ years experience in the production and supply of medicines to 11 countries comprising Switzerland, the Middle East and North Africa and expanding today in Europe. We aim to be a leading licensing partner in generic and specialty innovative medicines in our markets with an extensive portfolio of 70+ products in both the retail and hospital segments. We serve our communities by developing, manufacturing, and distributing high quality medicines covering major therapeutic areas such as musculo-skeletal, ophthalmology, anaesthetics, oncology, anti-infectives and women's health.
For more information, please visit our website: http://www.labatecpharma.com/about-us/
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