Regulatory Affairs Officer (Part-time)

Nivel cariera

Middle (2-5 ani)

Limbi vorbite

engleză, română

Adresa/ adresele jobului

București


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.
  • English:fluent.

THE OFFER

  • 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

Location: RO-Bucharest

Confidentiality is guaranteed! Only short listed candidates will be contacted!

Deadline for submitting applications: 5 December 2017