COMPANY OVERVIEW
A Japanese, herbal medicine  company is looking for a Reguratory Affaire/ Quality Assurance manager. Work location is in Berlin or South of Munich or Home Office base.

JOB RESPONSIBILITIES
          • Implementation of the EU GDP guidelines;
          • Maintenance and further development of a quality management system
          • Maintenance and further development of a pharmacovigilance system
          • Creation and review of quality agreements with third parties in accordance with   applicable laws
[AMG, AMWHV, AM-HandelsV, Medicines Advertising Ordinance, EU-GMP and -GDP guidelines]
            • Participation in the preparation of product releases.
            • Participation in documentation as part of the pharmacovigilance system
            • Participation in the development of new products
            • Supporting regulatory affairs activities
            • Communication with supervisory authorities
            • Carrying out official inspections
            • Participation in audits
            • Counseling and training of employees
QUALIFICATIONS

• Degree recognized in Germany as a natural scientist, ideally as a pharmacist;
• At least three years of quality assurance or management experience.
• Experience in dealing with authorities (Lageso, BfArM, EMA)
• Mastery of Word, Excel and PowerPoint;
• Confident bilingual written and oral command of German and English.

Apply online or feel free to contact me directly for more information about this opportunity. Due to the high volume of applicants, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.
 
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