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:

• Evaluation of documentation related to active substances or raw materials from external suppliers, as requested by Procurement or Regulatory Affairs
• Communicating comments with external suppliers / contractors through Procurement or directly
• Change control management related to any API changes within the assigned portfolio in all Zentiva sites
• Documentation support for on-time registration submissions within pharma projects and registration pipelines
• Documentation preparation in eDMS, including requested documentation (LoA, LoE, declarations…) for registration purposes
• DMF support within the registration procedures, including management of deficiency letters
• Valid documentation maintenance according to current legislation and notifications from contract partners
• Compilation of the applicant’s and restricted parts for Zentiva-developed active substances. Cooperation on projects and regulatory support.

We require:

• Degree in Chemistry or biomedical sciences (eg. Pharmacy/ Pharmaceutical Sciences/ Science), post-graduate in sciences as a plus
• Experience in Regulatory Affairs/Pharmaceutical industry
• Knowledge of relevant legislation in EU/non-EU countries
• Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.
• Fluent in both written and spoken English
• Ability to lead projects

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.
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• Evaluation of documentation related to active substances or raw materials from external suppliers, as requested by Procurement or Regulatory Affairs
• Communicating comments with external suppliers / contractors through Procurement or directly
• Change control management related to any API changes within the assigned portfolio in all Zentiva sites
• Documentation support for on-time registration submissions within pharma projects and registration pipelines
• Documentation preparation in eDMS, including requested documentation (LoA, LoE, declarations…) for registration purposes
• DMF support within the registration procedures, including management of deficiency letters
• Valid documentation maintenance according to current legislation and notifications from contract partners
• Compilation of the applicant’s and restricted parts for Zentiva-developed active substances. Cooperation on projects and regulatory support