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Manager Regulatory Affairs (m/f/d)

OmniVision GmbH is a growing, mid-sized company in the field of ophthalmology, headquartered in Germany with additional locations in Austria, Italy, Spain, and Switzerland. In Germany, OmniVision GmbH is among the leading independent ophthalmological companies not affiliated with a corporate group. Our product portfolio includes pharmaceuticals, medical devices, and dietary supplements.

Due to our strong growth, we are looking for a dedicated and motivated Manager Regulatory Affairs (m/f/d) to join our headquarters in Puchheim near Munich as soon as possible

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
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
IT affinity: eCTD, databases, Microsoft Office suite

What We Offer:

A permanent, long-term oriented position in a successful, owner-managed, mid-sized pharmaceutical company
An attractive compensation package
Opportunities for further training and development
30 days of annual leave
Flexible working hours, including mobile/remote work
A modern IT infrastructure
Modern, air-conditioned offices
Ergonomic workstations
Subsidized company pension scheme
Financial support for a company bike (JobRad)
Commuting allowance
Subsidized lunch, including free beverages
Seasonal fruit basket
Company events
EGYM Wellpass
Online portal for employee discounts via Corporate Benefits

Does this sound interesting to you?

We look forward to receiving your application, including a cover letter stating your salary expectations and earliest possible start date, your CV, and relevant references/certificates, addressed to Francisco Lopez, Senior HR Manager