Manager:in Regulatory Affairs

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:

Manager Regulatory Affairs (m/w/d) - Medicinal Products

Your contribution:

• 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

Your Profile:

• 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

We offer you:

• 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

Does this sound interesting to you?