Senior Regulatory Affairs Officer

hameln rds a.s.

Place of work
Horná 36, Modra
Contract type
full-time
Basic wage component (gross) and other rewards
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

Employee perks, benefits

• Extensive training
• 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.

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

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

Advertiser

Brief description of the company

Hameln rds offers services needed in bringing a pharmaceutical product into the market from a single source. With about 170 employees, we work with national and international customers from the pharmaceutical, biotechnological, chemical and medical technology industries.

For this purpose, we offer a complete value chain which is unique on the international healthcare market: from product development and laboratory services, preclinical and clinical studies, a full registration service including the handling of all issues related to existing registrations, through to the reliable supply of APIs and finished products including the necessary EU market approvals.

Number of employees

100-149 employees

Company address

hameln rds a.s.
Horná 36
900 01 Modra
http://www.hameln-rds.sk

Contact

Contact person: Ľudmila Šaturová
E-mail: send CV
ID: 3561596   Dátum zverejnenia: 17.12.2018   Základná zložka mzdy (brutto) a ďalšie odmeny:   from 1.500,- €