Regulatory Affairs Officer (Part-time)
Middle (2-5 ani)
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Regulatory Affairs Officer - 1 year external contract (Part-time) -
YOUR TASKS AND RESPONSIBILITIES
- Prepares, under Regulatory Affairs Head supervision high quality applications of clinical trials applications, necessary amendments and notifications and submits them to the local authorities according to the national and European requirements.
- Liaising with clinical project teams to procure documents required for regulatory submission.
- Regular Monitors progress of applications and communicates with the authorities in order to obtain timely approvals.
- Contributing to the preparation of answers to Authority requests in cooperation with Local and Global functions, documenting all relevant contacts in a factual manner, checking of incoming documents and initiating their correction, if needed.
- Tracking regulatory project documentation flow and progress reporting.
- Tracking changes/amendments to legislation requirements related to clinical research.
- Communication point for ethics committees and regulatory authorities.
- Timely and complete update of internal and external databases and document management systems, providing relevant information on RA milestones to the other functions on the local and global level.
- Timely approving all labeling documents and necessary changes according the local legislation and internal SOPs.
- Archiving of all documents and correspondence submitted to and received from the Authority according to the Global SOP and locally agreed processes.
- Regularly inform about changes in national legislation, changes which are related to Romanian registered products.
- Adherence to the global and local Standard Operating Procedures and Operational Manuals, company policies and internal rules.
WHO YOU ARE
- Technical expertise in managing regulatory aspects of clinical studies in Romania.
- At least two years’ experience in Regulatory Affairs for clinical research and knowledge of local regulatory environment.
- Life science related studies (pharmacy/medical, biology, chemistry).
- Excellent data recording and record keeping skills with a good eye for detail.
- Requires adequate communication, interpersonal and influencing skills.
- Team player.
- Proficiency in standard MS Office applications.
- Opportunity to work in a research based company with high ethical and work environment;
- Dynamic and involving job;
- Opportunities for training and development;
- Company benefits package;
- Fixed monthly salary.
Application time: until 5 December 2017
Reference Code: RA Officer
Division: Bayer - Regulatory Affairs
Confidentiality is guaranteed! Only short listed candidates will be contacted!
Deadline for submitting applications: 5 December 2017