Job Regulatory Affairs Manager MRC (m/w) Traunviertel siehe Beschreibung - Jobangebote

Berufsbezeichnung: Regulatory Affairs Manager MRC (m/w)

Arbeitsbeschreibung:
Remarkable developments occur at Sandoz due to the combination of individual characteristics, personal interests and professional qualification. This is why we are seeking employees with a passion for all that they do and who will work together with us to achieve the common goal: to provide patients in Austria and all over the world with high-quality, affordable pharmaceutical products. We, Sandoz, are one of the largest pharmaceuticasl companies in Austria with over 4.000 employees at four sites. As a member of the global Novratis Group, we develop, produce and market generic pharmaceuticals - above all antibotics, injectable cancer drugs and innovative biosimilars. Come and work with us as.... 1 Regulatory Affairs Manager MRC (m/w)

Area of Responsibility

* Timely preparation of high quality drug product Quality (CMC) documentation to support regulatory new submission.

* Write high-quality CMC documentation for marketed products to obtain rapid and advantageous registrations of changes and routine maintenance such as renewals and variations. Respect agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance.

* Prepare CMC responses to health authority questions during product registration and lifecycle

* Contribute as CMC expert to technical project team decisions during product lifecycle

* Identify the required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines

* Support and/or run MRC related projects

Qualifications

Education: University or academic degree in a science field (Chemistry, Pharmacy or equivalent)

Languages: Fluent (oral and written) in German and English

Experience:

* Preferred minimum of 2 years in the pharmaceutical industry, preferably in Regulatory Affairs

* Working knowledge of CMC documentation and change control process.

* Understanding of the regulatory requirements for CMC filings worldwide and critical evaluation of emerging requirements

* Team orientation

* Communication skills and initiative

Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, training possibilities and global career opportunities).

In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 42000 euros.

Please apply online under the following link: Online Application

www.sandoz.com/career/career opportunities/Job ID 177967BR

Contact: Leonardo Bruni, HR Manager

Tel.: +43 7665 8123 108

A-4866 Unterach am Attersee

Das Mindestentgelt für die Stelle als Regulatory Affairs Manager MRC (m/w) beträgt 42.000,00 EUR brutto pro Jahr auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.

Stunden pro Woche: 38,50

Angestelltenname: siehe Beschreibung

Arbeitgeber-Adresse: Unterach am Attersee

Form von Kontakt: Herr Leonardo Bruni

Arbeitgeber Telefonnummer: +43 7665 8123-115

Stellenkurzbeschreibung: Apotheker

Land: Österreich

Region: Traunviertel

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Uni/HS

Erfahrung: Gefordert

Quelle des Stellenangebots:
AMS, Öffentliche Arbeitsverwaltungen, Österreich

Fahrerlaubnis: Pkw bis 8 Personen; Lkw unter 3,5 t

Wie Sie sich bewerben: Bewerbung + Lebenslauf an den Arbeitgeber