Drug Regulatory Affairs (DRA) Expert
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Job Location:
Prague - Czech Republic
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
This position is during maternity/paternal leave.
Please send your CV in English language.
This position plays a crucial role in ensuring that all activities adhere to the highest standards of compliance with regulatory requirements company policies and industry best practices.
Drug Regulatory Affairs (DRA) Expert maintains oversight of the management of regulatory information and all other regulatory (DRA) activities ensuring compliance (Roche policies and procedures global and local regulatory requirements) and inspection readiness for the country within their area of responsibility.
The Opportunity
- Support the preparation of registration documentation for NP and MRP in the eCTD system
- Support and drive the drafting of Czech versions of Product Characteristics (SPCs) package leaflets and packaging material texts in collaboration with Medical Partners based on original English texts from PDR F. Hoffman La Roche Ltd. Reflecting the relevant regulations and legislation
- Participate during Launches Streamlines or Divestments of medicinal products
- Independently perform registration tasks for CP
- Train affiliate colleagues in the regulatory area as applicable
- Revision and update of SOPs for the DRA area
- Keep other centers Pharmacovigilance personnel Medical Director and Medical Partners informed about relevant regulatory updates and potential impacts on product marketing
- Make independent decision on changes implementation to be compliant with local regulations
- Hold accountability for the timely management and execution of regulatory processes information for Roche products in the Czech Republic within the Global Product Regulatory System (GPRS) and RIM
- Take responsibility for maintaining and regularly updating internal and external databases related to medicinal product registrations (e.g. MDMS Pharmdata)
- Manage the Direct Healthcare Professional Communication (DHPC) Dear Investigator Letter (DIL) and To Whom It May Concern Letter (TWIMCL) processes according to local procedures as needed
- Ensure the maintenance and regular updates of the local registration database for all Roche medicinal products registered in the Czech Republic
- Support and orchestrate the archiving of regulatory documentation in compliance with Information Compliance (COREMAP) rules
Who You Are
- Min. education level: University degree (Business Management preferred)
- Native level of the Czech language and fluency in English language
- Proven relevant work experience (3 years)
- Attention to detail and able to organize workload with the focus on priorities
- Demonstrable communication skills to be able to interpretate data guidelines and information to other colleagues and stakeholder in a clear manner
- Ability to work as part of a team
- Proven stakeholder management skills and the ability to effectively collaborate across a global organization
- Ability to influence act as a change agent build consensus and manage conflict in challenging situations
- Take lead on decision-making processes
- Self-aware and passionate about the regulatory area in a highly compliance-driven healthcare environment
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
