Sajnáljuk, de a hirdető cég már megszüntette az állásajánlat közzétételét a honlapunkon.
Megértését köszönjük.
Mutasd a hasonló álláshirdetéseket
Megértését köszönjük.
Mutasd a hasonló álláshirdetéseket
Senior Regulatory Affairs Officer
hameln rds s. r. o.
Place of work
Horná 36, Modra
Horná 36, Modra
Contract type
full-time
full-time
Wage (gross)
from 1.500,- €
from 1.500,- €
Information about the position
Job description, responsibilities and duties
• Regulatory support of development projects
• Evaluation of registration-relevant documents
• Participation in the joint development of new strategies and advice on scientific issues
from the point of view of drug law
• Preparation of EU dossiers with focus on quality documentation (CMC)
• Coordinating the application and monitoring of European drug approval procedures
and international projects for various active ingredients / finished products with
internal and external service providers
• Monitoring of internal deadlines and authorities deadlines
• Responding to inquiries from our partners and authorities at home and abroad
• Evaluation of registration-relevant documents
• Participation in the joint development of new strategies and advice on scientific issues
from the point of view of drug law
• Preparation of EU dossiers with focus on quality documentation (CMC)
• Coordinating the application and monitoring of European drug approval procedures
and international projects for various active ingredients / finished products with
internal and external service providers
• Monitoring of internal deadlines and authorities deadlines
• Responding to inquiries from our partners and authorities at home and abroad
Employee perks, benefits
• Extensive training
• Flat hierarchies
• Self-reliant and responsible work
• Participation in a dedicated team
• Exciting tasks
• Growing company
• Flexible working hours
• Flat hierarchies
• Self-reliant and responsible work
• Participation in a dedicated team
• Exciting tasks
• Growing company
• Flexible working hours
Information about the selection process
Ďakujeme všetkým záujemcom. Vyhradzujeme si právo kontaktovať len uchádzačov vhodných na inzerovanú pracovnú ponuku.
Zaslaním Vášho životopisu zároveň dávate súhlas so spracovaním Vašich osobných údajov uvedených v životopise za účelom výberu uchádzačov v zmysle Zákona č. 122/2013 Z.z. o ochrane osobných údajov.
Zaslaním Vášho životopisu zároveň dávate súhlas so spracovaním Vašich osobných údajov uvedených v životopise za účelom výberu uchádzačov v zmysle Zákona č. 122/2013 Z.z. o ochrane osobných údajov.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Educational Specialization
Pharmacy, Chemistry, Medicine or Biology
Language skills
English - Advanced (C1)
Other knowledge
Microsoft Excel - Advanced
Microsoft Word - Advanced
Microsoft Outlook - Advanced
Microsoft Word - Advanced
Microsoft Outlook - Advanced
Driving licence
B
Number of years of experience
3
Personality requirements and skills
• Degree in Science (preferably Pharmacy or Chemistry)
with at least 3 years' professional experience, ideally
in regulatory affairs in a pharmaceutical company in
the EU
• Good knowledge of the quality requirements for active
ingredients and finished medicinal products
• Good knowledge of national and international
regulatory requirements for new drug approvals and
maintenance (EU Drug Laws and Guidelines, WHO
Guidelines, ICH Guidelines, etc.)
• Very good knowledge of spoken and written English
• Secure handling of information processing tools (MS
Office, Adobe Acrobat)
• Strong communication skills and teamwork
• Willingness to interdisciplinary work
• High level of commitment, initiative, creativity and
resilience, perseverance and enthusiasm
• Willingness to travel and further education
with at least 3 years' professional experience, ideally
in regulatory affairs in a pharmaceutical company in
the EU
• Good knowledge of the quality requirements for active
ingredients and finished medicinal products
• Good knowledge of national and international
regulatory requirements for new drug approvals and
maintenance (EU Drug Laws and Guidelines, WHO
Guidelines, ICH Guidelines, etc.)
• Very good knowledge of spoken and written English
• Secure handling of information processing tools (MS
Office, Adobe Acrobat)
• Strong communication skills and teamwork
• Willingness to interdisciplinary work
• High level of commitment, initiative, creativity and
resilience, perseverance and enthusiasm
• Willingness to travel and further education
Advertiser
Brief description of the company
We, hameln rds s.r.o., located in Modra, Slovakia are part of the Hameln group, an internationally operating group of pharmaceutical companies with an European headquarters and a long-term corporate strategy. The main focuses are the development and the production of Active Pharmaceutical Ingredients (APIs) for sterile injectable pharmaceutical products and of all relevant services to market a pharmaceutical product (e.g. Stability testing, market release analysis, galenical development).
Number of employees
100-149 employees
Contact
ID: 3561596
Megjelentetés dátuma: 17.12.2018
2018-12-17
Régió: District Pezinok Pozíció: Chemist, Pharmacist, Regulatory Affairs Manager, Regulatory Affairs Specialist Cég: hameln rds s. r. o.
A (bruttó) bér alapösszetevője és egyéb juttatások: from 1.500,- €