Senior Regulatory Affairs Specialist
2 days ago
POSITION PURPOSE
As the Senior Regulatory Affairs Specialist, you will be responsible for the preparation, submission, and maintenance of regulatory documentation in compliance with applicable legislation. You will coordinate cross-functional efforts to support product registrations and ensure ongoing compliance throughout the product lifecycle. This position also involves close collaboration with internal and external stakeholders and requires active monitoring of regulatory developments to ensure alignment with current standards.
KEY RESPONSIBILITIES AND DUTIES
* To compile and prepare the registration documentation according to current guidelines with the aim to obtain marketing authorisation, variations approval, renewals, to implement DRA requirements into internal company standards.
* To compile, check and update registration documentation according to legislative requirements
* To cooperate with appropriate departments, to set partial tasks and check their realization for the purpose of controlling all the processes of registration proceedings
* Registration procedures Management: communication with internal and external partners, coordination of procedure
* Responsibility for products maintenance
* The active cooperation on the development/licence projects for the purpose of registration documentation preparation based on standard requirements of DRA
WE REQUIRE
* University degree in chemistry/natural science/pharmacy
* Experience in Regulatory Affairs at least 2 years
* Knowledge of the European DRA legislation
* Strong communication and organizational skills, presentation skills
* Advanced knowledge of English
Our Recruitment Process:
To be considered for this role, please apply in our Applicant tracking system and refrain from sending your CV via email. Upon the completion of sourcing (CV collection) period, all received application will be reviewed by our Recruitment experts and evaluated against the needs of the open role. Successful candidates will be contacted by our Recruiting experts for an initial screening interview during which further details about the selection process will be shared. Successful candidates will progress to interviews with line managers, while not selected candidates will be informed in a written form as soon as possible.
Diversity is a fact. Inclusion is an act @Zentiva
At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.
Join our winning team Be a part of our winning culture Be Zentiva
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