Pharmacist (m/w/d)
Key Job Details & Specifications
- Contract: KEINE_ANGABE
- Employment: Full-Time
- Work Model: Home Office / Hybrid / Remote Option Available
- Start Date: From 2026-10-07
- Work Location: 82178 Puchheim, Oberbayern, Germany
- Employer: OmniVisionĀ® GmbH
OmniVision GmbH 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 Regulatory Affairs (m/f/d) - Medicinal Products
to join our headquarters in Puchheim near Munich as soon as possible.
Planning and submission of national change notifications and EU-variations to competent authorities Compilation of variation packages regarding quality (CMC) and product information aspects
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 (LoQs))
Procurement and assessment of documents from international suppliers (Contract Manufacturing Organisations (CMOs)) Creation and revision of product information texts (SmPC, PIL, labelling) for the implementation of officially requested text 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 authorisation database
Collaboration in the company's internal change control process
Monitoring, interpretation and implementation of new regulatory requirements
University degree in natural sciences, preferably 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 in combination with an independent, structured and goal-oriented way of working Proactive thinking and acting, assertiveness, flexibility and strong communication skills Fluent in German and English with excellent oral 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