Senior Manager Regulatory Affairs (m/w/d)

OmniVision GmbH 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)

• Planning, coordination, timely compilation and submission of marketing authorisation dossiers for ophthalmological products with chemically defined substances (new developments, in-licensed products, export products)
• Management of marketing authorisation procedures within the EU (national, MRP/DCP)
• Development of regulatory strategies
• Review of marketing authorisation dossiers for in-licensing and planned marketing authorisation transfers (regulatory due diligence)
• Preparation of modules 1, 2, 4 and 5 with the partial involvement of external consultants
• Preparation of eCTD sequences and their submission to the competent  authorities via CESP or national submission portals
• Answering letters of deficiency (List of Questions (LoQs))
• Conduct of the national phases with the involvement of external consultants
• Planning, preparing and conducting scientific advice meetings (Scientific Advice)
• Coordination of regulatory activities in the OmniVision subsidiaries (Austria, Italy, Spain and Switzerland)
• Technical support for development projects
• Monitoring, interpretation and implementation of new regulatory requirements
• Maintenance and updating of the company's internal authorisation database
• Deputy head of the Regulatory Affairs department

• 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
• Sound knowledge of EU/ICH regulatory guidelines and regulations
• Open-minded personality
• Ability to lead a team
• Service-orientation
• Ability to grasp things quickly, analytical thinking combined with an independent and conscientious 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
• Excellent knowledge of Microsoft Office suite
• Experience in the creation of eCTD dossiers and the maintenance of Regulatory Information Management Systems (RIMS)

• A permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry
• An attractive remuneration package
• Further training opportunities
• Annual leave of 30 days
• Flexible working hours including mobile working
• A modern IT infrastructure
• Modern offices with employee parking spaces
• Subsidy for the company pension scheme
• Financial support for a job bike
• Payment of the Germany ticket
• Subsidized company catering including free drinks
• Company events
• Employee discounts (gym, shopping, travel, etc.)

OmniVision® ist ein innovatives, inhabergeführtes pharmazeutisches Familienunternehmen im Spezialgebiet der Augenheilkunde (Ophthalmologie).

Der Hauptfokus liegt in der Entwicklung und Vermarktung von ophthalmologischen Präparaten für Patienten, Augenärzte und Apotheker. Mehr