Worldwide Clinical Trials

Senior Specialist, Global Regulatory Affairs (EU)

Salary
Competitive
Posted
10 Oct 2018
Closes
08 Mar 2019
Ref
VN 1462

SUMMARY:        The Senior 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:

 

  • Liaise with the Regulatory Affairs Manager/Regulatory Affairs Director to plan, organise, compile progress and submit regulatory submissions on a timely basis
  • Coordinate, track & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
  • Provide advice on appropriate regulatory strategies
  • Stay abreast of changing regulatory legislative requirements and maintain regulatory intelligence database
  • Contribute towards the preparation of technical reports, which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions.
  • Review and make recommendations on 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, 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
  • Deputize for the Regulatory Affairs Manager/Director as required

 

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
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Ability to exercise sound judgment and make decisions independently
  • Excellent self-motivation skills
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint   
  • Good knowledge of ICH GCP
  • Good knowledge of EU Clinical Trials Directive

 

REQUIREMENTS:

 

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

 

 

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