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:
Senior Manager Regulatory Affairs (m/f/d) - Medicinal Products
* 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 Organizations (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
* Coordination of all regulatory lifecycle management activities in the OmniVision subsidiaries (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 authorization 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
* At least 5 years of professional and practical experience in regulatory affairs (medicinal products) within the EU
* Experience in creating eCTD sequences
* Open-minded personality
* Ability to lead a team
* Service-orientation
* Ability to grasp thinks quickly, analytical thinking in combination with an independent, structured and goal-oriented way of working
* Proactive thinking and acting, assertiveness, flexibility and strong communication skills
* For this position an excellent command of written and spoken German at the level of a native speaker (level C2) is required
* Fluent English with excellent verbal and written communication skills
* IT affinity: eCTD, databases, Regulatory Information Management Systems (RIMS), Microsoft Office suite
* Permanent, long-term employment in a successful, owner-operated medium-sized pharmaceutical company
* An attractive compensation package
* Professional development opportunities
* 30 days of annual vacation
* Flexible working hours including remote work options
* Modern IT infrastructure
* Modern and air-conditioned offices
* Ergonomic workstations
* Subsidized company pension plan
* Financial support for job bikes (company bicycle program)
* Coverage of the "Deutschlandticket" (nationwide public transportation ticket)
* Subsidized lunch including free beverages
* Seasonal fruit basket
* Company events
* EGYM Wellpass
* Online employee discount portal via Corporate Benefits
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