Associate Director Regulatory Affairs (m/f)

DACH, UK, Nordics

For our mandatory from the pharmaceutical industry we are searching as soon as possible for a dedicated and experienced

 

Associate Director Regulatory Affairs (m/f)

DACH, UK, Nordics

  • Bereich:

    Medical

  • Berufssparte:

    Zulassung/Regulatory Affairs

  • Arbeitsregion:

    Mannheim

  • Art der Anstellung:

    permanent

  • Kennziffer:

    24980

  • Aktualisierung:

    2018-10-15

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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 10 years experience in the pharmaceutical regulatory is required
  • Previous people management experience is required
  • Working knowledge of key health authorities in western EU and surrounding Eastern European countries
  • 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

Your contact person

Bettina Cöppicus
Senior Personalberaterin

Anschrift

Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg