SwixxBiopharma is a fast-growing pharmaceutical company providing a complete service to original multinational companies that do not have their own representation in our region.
Our team currently provides access to patients in the Czech Republic mainly to innovative medicines intended for the treatment of serious diseases from therapeutic areas such as haematology and haemato-oncology, oncology, nephrology or rare diseases.
Working in our company brings professional development in every position, where independence, initiative and creativity while maintaining all high compliance standards are an integral part of our job.
A non-financial benefit is the possibility of close cooperation not only with leading experts in the given therapeutic areas, but also the possibility to participate in the whole process when a new innovative drug enters practice in the Czech Republic.
- Ensuring compliance with local & EU legislation/ regulations, Company’s SOPs and Partner companies’ policies & procedures
- Overall responsibility for regulatory activities in cooperation with corporate functions for all Swixx and partners products’ according to the business agreement
- To ensure proper translation and quality check of product information in a timely manner
- Participatio in artwork preparation and management
- Timely sharing of information on new submissions and approvals to the relevant peers and partners’ companies according to business agreements
- To review promotional and non-promotional materials and approve those from regulatory point of view
- Effective co-operation with Corporate Functions, Regulatory Authorities and partner companies
- Ensuring that a quality management system is implemented and maintained in line with EU GDP guidelines and local requirements
- Organization of distribution activities
- Control of transport conditions and storage of the medicinal products
- Control over the contractual provider of distribution activities.
- Control over the suppliers and Customer.
- Complaint management activities
- Coordinating and promptly performing any recall operations
- Cooperate with the Authorities and other departments of the company and Partners
- Manage internal and external GxP audits
- Provides monitoring of legislation and update the documentation
What qualifications and competencies you should have:
- University degree preferably in Medicine, Pharmacy or Life Sciences, or alternatively in any other subject provided that person has sufficient work experience in industry or relevant governmental body
- Not less than 3 years regulatory / PV / Quality experience in pharma industry or any combination of education and experience which would provide necessary skills and qualification.
- Familiarity with industry standards, codes and relevant legislation, including regulatory requirements and standards
- High level of professionalism, ability and willingness to work effectively with multiple products, projects and partners in cross-functional team setting
- Orientation in the field of medicine and the pharmaceutical market
- Knowledge of English at Upper-Intermediate level
- Strong communication and presentation skills
- Prioritization and strategic planning skills
- Ability to work in changing environment
- Readiness for traveling on business purposes
- Team player investing in relationships
What we can offer to you:
- Working in a successful and fast-growing pharmaceutical company
- Excellent opportunity for personal and professional development
- Car, notebook and cell phone (also for personal use)
- Flexible working time, home-office
- 5 weeks holidays
- Modern offices in centre of Prague (2 minutes from Masaryk Railway Station and 5 minutes from Main Railway Station)
Informace o pozici
- Swixx Biopharma s.r.o.
- Hybernská 1034/5, Praha – Nové Město
- Required education: University
- Required languages: English (Advanced), Czech (Proficient)
- Benefits: Car for private purposes, Cell phone, Notebook, Contributions to the pension / life insurance, Flexible start/end of working hours, Holidays 5 weeks, Refreshments on workplace, Occasional work from home, Individual schedules of working hours
- Listed in: Pharmaceutical, Regulatory Manager
- Employment form
- Employment form: Full-time work
- Contract duration
- Contract duration: Permanent
- Employment contract
- Employment contract: employment contract
- Employer type: Employer