Manager:in Regulatory Affairs

OmniVision GmbH; München; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

OmniVision GmbH sucht einen erfahrenen Senior Manager Regulatory Affairs, um die regulatorischen Aktivitäten für Arzneimittel zu leiten. In dieser Rolle sind Sie für die Planung, Einreichung und Kommunikation mit Behörden verantwortlich und spielen eine Schlüsselrolle in der Produktzulassung und dem Lebenszyklusmanagement. Freuen Sie sich auf ein attraktives Vergütungspaket und zahlreiche Weiterbildungsmöglichkeiten in einem wachsenden Unternehmen der pharmazeutischen Industrie.

Leistungen

Attraktives Vergütungspaket

30 Tage Urlaub

Flexible Arbeitszeiten inkl. mobile Arbeit

Moderne IT-Infrastruktur

Finanzielle Unterstützung für Job-Bike

Subventionierte Unternehmensverpflegung

Qualifikationen

• Mehrere Jahre Erfahrung in der Regulierung von Arzneimitteln in der EU.
• Erfahrung in der Erstellung von eCTD-Sequenzen.
• Fähigkeit, strukturiert und zielorientiert zu arbeiten.

Aufgaben

• Planung und Einreichung von nationalen Änderungsmitteilungen und EU-Varianten.
• Kommunikation mit europäischen Behörden.
• Koordination aller regulativen Aktivitäten der Tochtergesellschaften.

Kenntnisse

Teamarbeit

Analytisches Denken

Kommunikationsfähigkeiten

Proaktive Denkweise

Ausbildung

Universitätsabschluss in Naturwissenschaften (Pharmazie, Biologie oder Chemie)

Tools

eCTD

Jobbeschreibung

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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
• 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
• 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 authorisation 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
• 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
• Native in German and English with excellent oral and written communication skills

We offer you:

• A permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry
• An attractive remuneration package
• Further training opportunities
• Annual leave of 30 days
• Flexible working hours including mobile working
• A modern IT infrastructure
• Modern offices with employee parking spaces
• Subsidy for the company pension scheme
• Financial support for a job bike
• Payment of the Germany ticket
• Subsidized company catering including free drinks
• Company events

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing

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