Specialist, Regulatory Affairs (Ukraine)
- 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.
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
- 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.