Pharmacist Biologist Chemist Regulatory Affairs (Remote)

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/f/d)

Your Contribution

• 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

Your Profile:

• 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 and English with excellent verbal and written communication skills
• IT affinity: eCTD, databases, Microsoft Office suite

We offer you:

• 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 offices with employee parking
• Subsidised company meals including free drinks
• Financial support for a job bike
• Payment of Germany ticket
• Subsidized company catering including free drinks
• Company events
• Employee discounts (gym, shopping, travel, etc.)