Regulatory Affairs Coordinator
nr ref: 30/9/2024/EM/88013
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.
Location: Gdańsk
We work: Hybrid (80% from home)
Working hours: shifts: 9 AM- 5 PM or 3 PM - 11 PM
Contract of employment: full-time
Level: Mid / Senior
Recruitment process: online
About your future employer:
Our Client is dedicated to helping the world's leading companies build stronger businesses with operations and offices worldwide.
As a global player, it can give you the chance to follow training and development programs of all types, and to explore career opportunities and experiences in other countries and departments.
Regulatory Affairs Coordinator
Here are some of the things you can look forward to:
- Act as the first-level support and guide junior staff in compiling regulatory documentation, ensuring that all quality targets are met and validation errors are resolved.
- Perform technical quality control of dossier documents and complex submissions to ensure compliance with both internal and external standards.
- Collaborate with relevant stakeholders during the preparation and quality control of reports and regulatory documentation.
- Provide additional support for other regulatory-related activities as needed by the business.
Essential Skills and Qualifications:
- Previous experience in electronic submission publishing, dossier management, and the dispatch of regulatory dossiers across various regions.
- Demonstrated experience in publishing complex and major submissions, including modules 3, 4, and 5.
- Strong knowledge of global regulatory processes within the pharmaceutical industry and submission publishing requirements.
- Proficiency with electronic document management systems and publishing tools, along with a deep understanding of document publishing.
- Excellent verbal and written communication skills.
- High level of organizational awareness and attention to detail.
- Advanced level of English.
We offer:
- Comprehensive training to ensure success in your role
- Technical or managerial career path (everyone can develop their leadership skills)
- Be a part of a truly awesome team in a well - located office in Gdańsk
- Opportunity for professional development in an international environment and for increasing your abilities and skills in various areas
- Life insurance
- Private medical care
- Flexible working hours
- Great atmosphere and comfortable working conditions
- Stable job and cooperation with friendly and high qualified team
- Soft skills development
- Hybrid model of work
- Integration events
- International team and non-corporate work enviroment
Recruitment proces:
- Short interview with Antal Consultant
- Interview with HR & Hiring Manager
- Employment
What is Antal?
Recruitment company!
We are the leader in the recruitment of specialists and managers, as well as in HR consulting. The brand is present in 35 countries and has been operating in Poland since 1996. During this time we built many candidates' careers, thanks to our flexible and comprehensive approach to all recruitment processes. Our specialists, completely free of charge, will help you find and get the best job for you!
What will you gain by applying for Antal job offer?
Free career support!
By applying for Antal offers, you will receive support from our Consultant, who will keep in touch with you via e-mail or phone, help you prepare for the interview, and take care of the quality of the recruitment process.
