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Regulatory Specialist (Switzerland) (m/f/d), 50%, hybrid, Luzern
As a Regulatory Affairs (RA) Specialist for Switzerland you will be responsible for all RA submission requirements for assigned product portfolio as applicable. You will collaborate with colleagues (1 Director, 2 RA Specialists) to ensure compliance with local laws and regulations, including backing up colleagues. You will be also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of local RA agreements, participation in audits and inspections and related readiness activities.
- Responsible for execution of local RA processes and activities in alignment with RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
- Assist in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards
- Files, stores, updates and archives regulatory data and documentation in accordance with department and company policies and local requirements.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Health, life science, or medical science degree or equivalent by education
- 1-3 year of industry experience in regulatory affairs
- Must have a general knowledge of RA regulations within his/her assigned country and be an expert in RA processes/activities.
- Good communication and time management skills
- Fluent in English (written and spoken) while proficient in local language
Are you interested? We look forward to receiving your application.
Please apply online. For more information about this position, please contact your Kelly recruiter Ms. Susanne Junker (+41 76 335 16 58), You can find other interesting positions on our website: www.kellyservices.ch