Start Date
Immediate
Expiry Date
18 Sep, 25
Salary
0.0
Posted On
19 Jun, 25
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Good communication skills
Industry
Pharmaceuticals
Job Purpose:
We are seeking a Regulatory Active Substances Specialist to support the management of Drug Master Files (DMFs) across all Zentiva sites. The role includes evaluating external documentation related to active pharmaceutical ingredients (APIs), such as Active Substance Master Files (ASMFs), Certificates of Suitability (CEPs), and Technical Packages (TPs). Responsibilities also include preparing documentation and providing DMF support during registration procedures, maintaining API documentation within the assigned portfolio in accordance with current legislation and information from external partners, and managing change control processes related to API changes. Additionally, the role involves compiling ASMFs for in-house developed projects.
Your responsibilities:
We require:
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