Worldwide Clinical Trials

Specialist, Regulatory Affairs (Ukraine)

Salary
Competitive
Posted
21 Nov 2018
Closes
17 Jan 2019
Ref
VN 1456
Discipline
Regulatory Affairs

SUMMARY:        The Specialist, Global Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle.


RESPONSIBILITIES:

Tasks may include but are not limited to:

  • Under the direction of a senior member of the department, coordinate, track & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
  • Stay abreast of changing regulatory legislative requirements and maintain regulatory intelligence database
  • Review all relevant documentation e.g. labels, patient information sheets, diary cards etc…to ensure compliance with ICH GCP & country specific requirements
  • Effectively communicate status of submissions with the Sponsor, Head of Regulatory Affairs, Project Manager, RAL, CSSL, RCL, SCL, CRAs, Medical & Scientific Affairs staff.
  • Comply with SOPs, ICH GCP and national regulations as applicable
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers

 

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

 

OTHER SKILLS AND ABILITIES:

  • Clearly, proven organizational management skills are essential attributes
  • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Ability to exercise sound judgment and excellent self-motivation skills
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
  • Clear understanding of ICH GCP across all areas

 

REQUIREMENTS:

  • Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Previous experience within the pharmaceutical industry/CRO industry

 

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.