Jobbeschreibung
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.)