Specialist, Global Regulatory Affairs (Ukraine-Home based)

We are seeking a Specialist, Global Regulatory Affairs to join our growing team!

You will find an excellent work life with a group that values teamwork.  Be a part of this global team at the best mid-sized CRO!  If you are a motivated quick learner with a desire to grow your career apply now.

This role is full time, permanent and can be based anywhere in the Ukraine.

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