Regulatory & Quality Affairs Manager - Pharmacy

Mikuláš & Partners, s.r.o.

Place of work
Brno - City
Contract type
full-time
Start date
asap
Wage (gross)
80.000 CZK

Information about the position

Job description, responsibilities and duties

• Responsible for the initiation and conduct of the registration procedure of medicinal products and maintaining the validity of the registration decision in accordance with applicable legislation and requirements of the company
• Prepares local documents and text translations for the registration of medicinal products
• Responsible for the registration and notification of medical devices
• Responsible for preparing the notification of food supplements and cosmetics
• Communicates with employees of SIDC, Ministry of Health, VZP, Ministry of Finance, with professional health experts and professional medical / pharmaceutical organizations
• Monitors legislation in the field of drug regulation, medical devices, dietary supplements, cosmetics and monitors developments in the industry
• Approve the promo materials
• Communicates with the logistics, sales and marketing departments
• Manages department budget
• Proposes a process improvement in the department

Employee perks, benefits

- motivated salary + benefits
- flexible working hours - one day home office,
- additional week of holiday,
- food vouchers and other benefits

Company on whose behalf the position is being filled

Chemical industry, manufacture of pharmaceutical products

Our client is the international pharmaceutical company

Requirements for the employee

Candidates with education suit the position

University education (Master's degree)
Postgraduate (Doctorate)

Language skills

English - Upper intermediate (B2)

Driving licence

B

Number of years of experience

3

Personality requirements and skills

• University degree pharmaceutical / medical / natural science
• Experience in Regulatory Affairs or a related field (QA / QC, production, development) at least 3 years
• Knowledge of the European and local legislation (LP, ZP, nutritional supplements, cosmetics)
• Excellent communication skills, decision-making and organizational skills - managerial experience is an advantage
• Working knowledge of English

Advertiser

Brief description of the company

We are the consulting and trading company operating in CEE region.

The company is a holder of a licence to offer recruitment services.

Number of employees

1 employee
ID: 2628689  Datum zveřejnění: 1.7.2016  Základní složka mzdy (brutto) a další odměny: 80.000 CZK