OmniVision GmbH | Germany | 82xxx Puchheim | Permanent position | Full time / Home office | Published since: 11.08.2026 on stepstone.de
Manager Regulatory Affairs (m/f/d)
is a growing, mid-sized company in the field of ophthalmology, headquartered in Germany with additional locations in Austria, Italy, Spain, and Switzerland. In Germany, OmniVision GmbH is among the leading independent ophthalmological companies not affiliated with a corporate group. Our product portfolio includes pharmaceuticals, medical devices, and dietary supplements. Due to our strong growth, we are looking for a dedicated and motivated Manager (m/f/d) to join our headquarters in Puchheim near Munich as soon as possible. .
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Your tasks • Your profile • What we offer
Planning and submission of national change notifications and EU-variations to competent authorities Planning and submission of renewal applications Management of national and European variation and renewal procedures Communication with European competent authorities (EU and Switzerland) Answering letters of deficiency (List of Questions) Procurement and assessment of documents from international suppliers (Contract Manufacturing Organisations) Creation and revision of product information texts (SmPC, PIL, labelling) for the implementation of original amendments and/or for text adaptations to the current state of knowledge Creation of eCTD sequences for the submission of variation and renewal applications Maintaining and updating the company's internal marketing Collaboration in the company's internal change control process Monitoring, interpretation and implementation of new regulatory requirements
University degree in natural sciences, preferably in Pharmacy, Biology or Chemistry Several years of professional and practical experience in Regulatory Affairs (medicinal products) within the EU Experience in creating eCTD sequences Ability to work in a team, service orientation Quick comprehension, analytical thinking combined with an independent, structured and goal-oriented work Proactive thinking and acting, assertiveness, flexibility and strong communication skills Fluent in German and English with excellent verbal and written communication skills IT affinity: eCTD, databases, Microsoft Office suite
A permanent, long-term oriented position in a successful, owner-managed, mid-sized pharmaceutical company An attractive compensation package Opportunities for further training and development 30 days of annual leave Flexible working hours, including mobile/remote work A modern IT infrastructure Modern, air-conditioned offices Ergonomic workstations Subsidized pension scheme Financial support for a company bike (JobRad) Community allowance Subsidized lunch, including free beverages Seasonal fruit basket Company events EGYM Well Pass Online portal for employee discounts via Corporate Benefits
Location
 | OmniVision GmbH | |
| 82178 Puchheim | ||
| Germany |
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