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Senior Manager Regulatory Affairs (m/w/d) - Medicinal Products

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:

Senior 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 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

Your Profile:

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

We offer you:

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

Does this sound interesting to you?

We look forward to receiving your application (cover letter stating your salary expectations and earliest possible starting date, CV and references) to the attention of Francisco Lopez, HR Manager.