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:
Senior Manager Regulatory Affairs (m/f/d)
- Planning, coordination, timely compilation and submission of marketing authorisation dossiers for ophthalmological products with chemically defined substances (new developments, in-licensed products, export products)
- Management of marketing authorisation procedures within the EU (national, MRP/DCP)
- Development of regulatory strategies
- Review of marketing authorisation dossiers for in-licensing and planned marketing authorisation transfers (regulatory due diligence)
- Preparation of modules 1, 2, 4 and 5 with the partial involvement of external consultants
- Preparation of eCTD sequences and their submission to the competent authorities via CESP or national submission portals
- Answering letters of deficiency (List of Questions (LoQs))
- Conduct of the national phases with the involvement of external consultants
- Planning, preparing and conducting scientific advice meetings (Scientific Advice)
- Coordination of regulatory activities in the OmniVision subsidiaries (Austria, Italy, Spain and Switzerland)
- Technical support for development projects
- Monitoring, interpretation and implementation of new regulatory requirements
- Maintenance and updating of the company's internal authorisation database
- Deputy head of the Regulatory Affairs department
- University degree in natural sciences, preferably Pharmacy, Biology or Chemistry
- At least 5 years of professional and practical experience in regulatory affairs (medicinal products) within the EU
- Sound knowledge of EU/ICH regulatory guidelines and regulations
- Open-minded personality
- Ability to lead a team
- Service-orientation
- Ability to grasp things quickly, analytical thinking combined with an independent and conscientious 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
- Excellent knowledge of Microsoft Office suite
- Experience in the creation of eCTD dossiers and the maintenance of Regulatory Information Management Systems (RIMS)
- 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.)