Pharmazeut (m/w/d) (Pharmazeut/in)

Description du poste

 
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/f/d)
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

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

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.)