Job Description
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) - Medicinal Products
- 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 Organizations (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
- Coordination of all regulatory lifecycle management activities in the OmniVision subsidiaries (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 authorization database
- Collaboration in the company's internal change control process
- Monitoring, interpretation and implementation of new regulatory requirements
- 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
- Experience in creating eCTD sequences
- Open-minded personality
- Ability to lead a team
- Service-orientation
- Ability to grasp thinks quickly, 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, Regulatory Information Management Systems (RIMS), Microsoft Office suite
- Permanent, long-term employment in a successful, owner-operated medium-sized pharmaceutical company
- An attractive compensation package
- Professional development opportunities
- 30 days of annual vacation
- Flexible working hours including remote work options
- Modern IT infrastructure
- Modern and air-conditioned offices
- Ergonomic workstations
- Subsidized company pension plan
- Financial support for job bikes (company bicycle program)
- Coverage of the "Deutschlandticket" (nationwide public transportation ticket)
- Subsidized lunch including free beverages
- Seasonal fruit basket
- Company events
- EGYM Wellpass
- Online employee discount portal via Corporate Benefits