Regulatory Affairs Officer - Regulatory Operations

MISSION STATEMENT

Under supervision, executes administrative and specific RA activities to support Regulatory Operations team and RA organization, completes low-risk regulatory assignments, performs relevant regulatory data entry and maintenance, supports tasks related to implementation and maintenance of RA information systems used for the relevant processes, supports regulatory reporting. Provides regulatory support to key internal/external customers.

MAIN ACCOUNTABILITIES AND DUTIES

• Assistance with defined tasks of IT projects related to the respective RA information systems development, implementation and enhancement
• Under supervision, execution of data administration in regulatory databases including data entry within RegOps responsibilities
• Assistance with the process of Marketing Authorizations management
• Support of TSA and integration
• Communication with peers and supervisors and alignment on issues, questions, and goals
• Support of the preparation and compilation of the monthly reports, training matrix, KPIs  
• Support of checking and upload of regulatory documentation to Regulatory systems according to legislative and department requirements
• Assistance with the scheduling of meetings with internal / external stakeholders and development and organization of materials for these meetings, agenda, and meeting minutes
• Maintenance of designated department Share Points and web information/materials
• Identification and escalation of areas of administrative process improvement
• Regulatory support to stakeholders and customers, as required

REQUIRED QUALIFICATIONS & EXPERIENCE  

• Secondary school degree required; university degree in chemistry, pharmacy, or life sciences is a plus.
• 0 to 2 years of working experience, previous experience in pharma industry as a plus
• IT knowledge – experience in working with databases and data management as a plus

REQUIRED COMPETENCIES & SKILLS

• Acts in line with Zentiva Superpowers principles and values
• Good communication skills, both verbal and written, with a passion for accuracy and attention to detail
• Good interpersonal skills – ability to effectively interact with a diverse group of people from different functions, of different nationalities and at different levels within the company
• Ensure personal compliance with relevant quality standards
• Learning agility and listening skills - ability to accept feedback as opportunity to learn and improve
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities
• Good written and oral 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!