Senior Regulatory Affairs Specialists
ref nr: 281/8/2024/AK
Gdańsk (pomorskie), Poznań (wielkopolskie)
August 29, 2024
In Antal we have been dealing with recruitment for over 20 years. Thanks to the fact that we operate in 10 specialised divisions, we have an excellent orientation in current industry trends. We precisely determine the specific nature of the job, classifying key skills and necessary qualifications. Our mission is not only to find a candidate whose competences fit the requirements of the given job advertisement, but first and foremost a position which meets the candidate’s expectations. Employment agency registration number: 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
