Regulatory Submissions Publisher

Recruiter
SRG
Location
Richborough, UK
Salary
Competitive
Posted
24 Aug 2019
Closes
28 Aug 2019
Ref
1243816232
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
SRG are recruiting on behalf of a Global Pharmaceutical Company who have opened a new vacancy and are looking to recruit a Regulatory Submissions Publisher on an initial 6 Month contract to be based at their offices in Kent.

Responsibilities:
  • Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
  • Adhere to quality control procedures and standards related to submission publishing.
  • Adhere to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure Regulatory compliance.
  • Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
  • Responsible for key projects within a specific region to implement and train on any external agency updates for procedures or requirements
  • Responsible for leading major submissions. Coordinating the allocation of all publishing activities around the global publishing hubs to meet agreed deadlines, whilst tracking and monitoring all issues.
  • Liaise with Global Submission Managers, Hub Submission Managers and contributing lines to discuss and agree expectations and publishing timelines.
  • Monitor local mailbox for any urgent publishing requests.
  • Support global/local publishing teams when the need arises
  • Adhere to compliance standards

Education/Skills:
  • Degree minimum in any Life Sciences
  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
  • Functional and technical knowledge and skills to do the job at a high level of accomplishment
  • Proven technical aptitude
  • Experience of using publishing tools such as Liquent InSight and proven knowledge of eCTD formats
  • Quick learner with ability to multi-task
  • Ability to work with accuracy and attention to detail
  • Ability to work with autonomy and/or part of a team in a busy environment
  • Demonstrated ability to work in a highly regulated environment
  • Demonstration of experience working in a customer service environment


If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@SRG.co.uk or +441753 589673

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