Manager Regulatory Affairs (m/f/d) - Medicinal Products

OmniVision GmbH is a growing, mid\-sized company in the field of ophthalmology, headquartered in Germany with additional locations in Austria, Italy, Spain, and Switzerland. In Germany, OmniVision GmbH is among the leading independent ophthalmological companies not affiliated with a corporate group. Our product portfolio includes pharmaceuticals, medical devices, and dietary supplements.

Due to our strong growth, we are looking for a dedicated and motivated Manager Regulatory Affairs (m/f/d) to join our headquarters in Puchheim near Munich as soon as possible

Your contribution:
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• 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 Organisations (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


• 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 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 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, Microsoft Office suite

• A permanent, long\-term oriented position in a successful, owner\-managed, mid\-sized pharmaceutical company


• An attractive compensation package


• Opportunities for further training and development


• 30 days of annual leave


• Flexible working hours, including mobile/remote work


• A modern IT infrastructure


• Modern, air\-conditioned offices


• Ergonomic workstations


• Subsidized company pension scheme


• Financial support for a company bike (JobRad)


• Commuting allowance


• Subsidized lunch, including free beverages


• Seasonal fruit basket


• Company events


• EGYM Wellpass


• Online portal for employee discounts via Corporate Benefits

We look forward to receiving your application, including a cover letter stating your salary expectations and earliest possible start date, your CV, and relevant references/certificates, addressed to Francisco Lopez, Senior HR Manager

Karrierestufe

mit Berufserfahrung

Arbeitszeit

Vollzeit

Standorte

Lindberghstraße 9, 82178 Puchheim, Deutschland

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Arbeitsverhältnis

Festanstellung

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