Senior Regulatory Affairs Specialists
nr ref: 281/8/2024/AK
Gdańsk (pomorskie), Poznań (wielkopolskie)
29 sierpnia 2024
W Antal zajmujemy się rekrutacją od ponad 20 lat. Dzięki działaniu w 10 wyspecjalizowanych dywizjach, świetnie orientujemy się w aktualnych trendach branżowych. Precyzyjnie określamy specyfikę stanowiska, klasyfikując kluczowe umiejętności i niezbędne kwalifikacje. Naszą misją jest nie tylko znalezienie kandydata, którego kompetencje wpisują się w wymagania danego ogłoszenia, ale przede wszystkim stanowiska, spełniającego oczekiwania kandydata. Numer rejestru agencji zatrudnienia: 496.
Senior Regulatory Affairs Specialists
Requirements:
- Responsible for global regulatory submission / dossier publishing day-to-day activities and deliverables
- Compilation and maintenance of regulatory documentation as per the procedure in client repository
- Performing high level of files’ formatting using the client provided software (creating bookmarks, hyperlinks, file optimization etc.
- Performing technical quality control of dossier documents ensuring adherence to internal and external document standards
- Interacting with relevant stakeholders during preparation and quality control of reports and regulatory documentation
- Providing input and advice to project on relevant aspects of the submission process
- Supporting the client in aligning the process maps/SOPs/WI as per recent updates
- Providing support to other regulatory related activities as per the business requirements
- Associates to ensure Training & compliance to applicable CTS and BI "Quality Management System”. Following and establishing processes and procedures in the team and adhering to Client work instructions and procedures
- Compliance with KPI’s
- Customer satisfaction index
Responsibilities:
- Science, computer science or engineering degree
- More than 1 year of experience in pharmaceutical / Medical Device / any related industry, with relevant experience in electronic submission publishing, dossier management and dispatch of regulatory dossiers (US, EU, Asia, Latin America, etc)
- Expert in submission publishing requirements globally
- Strong knowledge of Regulatory processes
- Excellent verbal and written communication skills
- Demonstrated ability to be innovative and a creative thinker
- High level of organizational awareness
- Experience with electronic document management systems, publishing tools, knowledge of documents publishing/document management
- Experience in eCTD publishing (this is a must)
We offer:
- Competitive salary compensation
- Private medical care, including dental care
- Life insurance
- Annual bonus
- Great system of bonuses, including MyBenefit Platform, MultiSport Card, Holiday subsidy
- Additional days off
- Career development opportunities
