Senior Regulatory AffairsManager (m/w/d) DACH, UK, Nordics

68161 Mannheim
04.02.2019

Daten dieser Anzeige

Job-ID: 009554457
Senior Regulatory AffairsManager (m/w/d) DACH, UK, Nordics

über OPTARES GmbH & Co. KG

Germany

https://www.bewerbung2go.de/erstellen/apply/1BO/009554457

Assist EU regulatory director, & manage local regulatory professionals to obtain and maintain all necessary pharmaceutical Marketing Authorisation approvals Liaise directly with local health authorities to develop and lead Ensure the registration and regulatory compliance of locally marketed products Amend registration dossiers as necessary for country-specific regulatory requirements and submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues Interface with local government agencies and industry associations Work with regional and country commercial directors & provide supports to local drug listings and promotional material copy clearance activities Represent company interests with local government agencies, industry associations and/or other organizations Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products Provide regulatory supports to activities related to SOPs & training programs and regulatory compliance in the areas of regulatory affairs and pharmacovigilance

For our mandatory from the pharmaceutical industry we are searching as soon as possible for a dedicated and experienced Senior Regulatory Affairs Manager (m/w/d) DACH, UK, Nordics Standort: Mannheim Kennziffer: 24980 Your tasks Assist EU regulatory director & manage local regulatory professionals to obtain and maintain all necessary pharmaceutical Marketing Authorisation approvals Liaise directly with local health authorities to develop and lead Ensure the registration and regulatory compliance of locally marketed products Amend registration dossiers as necessary for country-specific regulatory requirements and submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues Interface with local government agencies and industry associations Work with regional and country commercial directors & provide supports to local drug listings and promotional material copy clearance activities Represent company interests with local government agencies, industry associations and/or other organizations Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products Provide regulatory supports to activities related to SOPs & training programs and regulatory compliance in the areas of regulatory affairs and pharmacovigilance Your qualifications Advanced degree in Pharmacy/Chemistry/Biology or other science-related field A minimum of 3-5 years experience in the pharmaceutical regulatory is required Working knowledge of key health authorities in western EU and surrounding Eastern European countries preferred Experience in narcotic pharmaceutical business is a preferred Able to effectively influence senior management and functions to drive change and improvement Strong ability to review & see beyond the detail of the numbers and identify issues and opportunities in the business Strong analytical skills - including commercial, financial acumen and budget management Flexible to travel if required English language skills are required About us Seit 2003 vermittelt Optares Medical erfolgreich Fach- und Führungskräfte an Unternehmen der pharmazeutischen, biotechnologischen und medizin­technischen Industrie. Dabei profitieren Sie als Kandidat durch unsere langjährige Branchenexpertise und unser weit reichendes Netzwerk zu den jeweiligen Entscheidungsträgern. Wir ermöglichen Ihnen somit den Zugang zu passgenauen Positionen inklusive echten Herausforderungen und entsprechenden Weiter­ent­wick­lungs­möglichkeiten. Die professionelle, diskrete und transparente Betreuung unserer Kandidaten während des gesamten Bewerbungsprozesses steht dabei für uns im Mittelpunkt. Your application Ihre Ansprechpartnerin Frau Bettina Cöppicus Senior Personalberaterin Tel. +49 5272 3931505 bettina.coeppicus@optares.de   Optares GmbH & Co. KG Personalberatung und -vermittlung Heiligengeist Höfe 8 26121 Oldenburg www.optares.de Folgen Sie uns auf Folgen Sie uns auf Xing LinkedIn Twitter

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

68161 Mannheim