Manager:in Regulatory Affairs

Stellenbeschreibung:

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