Regulatory Affairs Associate

Preparation of locally required documents for submission and procedures of new MAA, variations to MA, renewal, and other regulatory procedures (including the application forms, declarations, national version of product information texts, responses to questions, etc.) within the requested deadlines.
• Ensuring of regulatory compliance within all product portfolio.
• Co-operation on preparation of submission strategy from national level.
• Co-operation and negotiation with local Authorities (SIDC, MoH).
• Co-operation with and support of HQ.
• Sufficient knowledge of national law and guidelines, as well as European directives, and their effect to all processes.
• Overview of company's SOPs and guidelines and their compliance.
• Co-operation on preparation of local SOPs and ensuring their compliance.
• Acting as LDSO deputy with all pharmacovigilance responsibilities and duties national level according to national law, European directives, and Company's guidelines and processes (including but not limited to reporting of ADR, preparing of compliance reports, supervising compliance with the guidelines, etc).
• Ensuring appropriate PhV training for all staff on national level.
• Overview of patent situation for forthcoming launches and co-operation with IP department at HQ in this regard.
• Co-operation on new product introduction (NPI) processes.
• Providing the necessary advice on regulatory, product and medical issues.
• Partial responsibility for quality standards, product recalls and compliance with registered details.
• Preparation of Summary ofProduct Particulars (SPP) for national licences and necessary updates in line with registered details.
• Preparation of the artworks, request for artworks revision and implementation.
• Update of regulatory databases (central regulatory, internal)

- Very interesting and responsible job in a multinational company
with attractive portfolio
- International working environment
- Possible professional development
- A high degree of self-realization

Žiadosti o zamestnanie spolu so životopisom a súhlas na spracovanie osobných údajov zasielajte mailom.

Vopred sa ospravedlňujeme, ale vzhľadom na veľké množstvo zaslaných žiadostí o zamestnanie nie je možné odpovedať všetkým z Vás. Po starostlivom posúdení všetkých žiadostí, budeme kontaktovať iba uchádzačov postupujúcich do ďalšieho výberového kola a ostatné žiadosti spolu so životopismi budú skartované podľa zákona č. 428/2002 Z. z. o ochrane osobných údajov. Ďakujeme za pochopenie a za prejavený záujem