Job Description
is an expanding medium-sized ophthalmology company with its headquarters in Germany and locations in Austria, Italy, Spain and Switzerland. In Germany, OmniVision GmbH is one of the leading non-corporate ophthalmology companies. Our product portfolio includes pharmaceuticals, medical devices and nutritional supplements.
In the course of our strong growth, we are looking for a committed and motivated person to join our headquarters in Puchheim near Munich as soon as possible:
Regulatory Affairs Manager (m/f/d)
with German language skills at level C2 or native speaker level
* 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
* Liaise 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) to implement regulatory changes and/or to adapt texts to the current state of knowledge
* Coordination of all regulatory lifecycle management activities in the OmniVision subsidiaries in Austria, Italy, Spain and Switzerland
* 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 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 style
* Proactive thinking and acting, assertiveness, flexibility and strong communication skills
* Fluent in German (level C2 or native speaker level) and English with excellent verbal and written communication skills
* IT affinity: eCTD, databases, Microsoft Office suite
* A permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry
* An attractive remuneration package
* Training opportunities
* 30 days annual leave
* Flexible working hours including mobile working
* Modern IT infrastructure
* Modern, air-conditioned offices
* Ergonomic workstations
* Modern, air-conditioned offices
* Ergonomic workstations
* Contribution to company pension scheme
* Financial support for a job bike
* Payment of 'Germany ticket'
* Subsidised lunch with free drinks
* Seasonal fruit basket
* Company events
* EGYM Wellpass
* Online portal for employee discounts via Corporate Benefits
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