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Job Details

Regulatory Operations Associate

Company: Kyowa Kirin International plc
Location: Galashiels, Scottish Borders
Reference: TJK4X81
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits: Pension scheme, Private medical insurance, Other voluntary benefits include: Childcare Vouchers, Bike to Work

Job Summary:

Provide support to the Regulatory Affairs team in the creation, publishing and tracking of submissions and other regulatory documents with electronic tools and specialised software.

Requirements:

About Kyowa Kirin International

Kyowa Kirin International is going through an exceptional time.  With three product launches expected over the next three years and further new product development combined with excellent international growth rates, we are providing a great platform for today and our future.

 

Kyowa Kirin International plc is owned by Kyowa Hakko Kirin Co., Ltd (KHK) of Japan. Founded in 1949, KHK has a successful track record in Japan and is now expanding globally. Our highly successful product portfolio, enviable pipeline and active Business Development group provides a wealth of products in the therapeutic areas of Oncology, CNS and Nephrology. With three key anti-body therapies in late stage development Kyowa Kirin is setting the scene for transformative growth.

 

Regulatory Operations Associate

Provide support to the Regulatory Affairs team in the creation, publishing and tracking of submissions and other regulatory documents with electronic tools and specialised software.

 

  • Coordinate the publishing and submission of electronic documents to regulatory authorities
  • Advise and support the Regulatory team in their preparation of scientific and regulatory documents for use in electronic regulatory submissions with regard to electronic requirements and formatting
  • Use and manage the electronic systems used by the Company to prepare, publish, submit and maintain regulatory submissions; Systems include electronic document management, regulatory tracking and eCTD
  • Provide appropriate training to users of these electronic systems/tools
  • Support the development and implementation of procedures and processes for use of these electronic systems/tools
  • Provide customer support to resolve user's issues with electronic systems/tools and interfaces with the IT Department where necessary
  • Support evaluation and approval of any new release of the systems being used.
  • Assist with the evaluation and implementation of document management tools, electronic publishing systemsand RIMS
  • Assist in interpreting and enforcing electronic regulatory submission standards, policies and operating procedure requirements
  • Maintain a high level of knowledge of regulatory requirements for electronic submissions and industry trends and standards

 

About you

  • Bachelor’s degree (or equivalent experience) with at least 2 years Regulatory Operations and pharmaceutical industry experience required
  • Experience preparing eCTD using electronic publishing system and tools, and with electronic Document Management Systems (eDMS)
  • Solid knowledge of ICH guidance
  • Proficiency with MS-Office Suite and Adobe Acrobat applications
  • Ability and flexibility to balance multiple tasks to meet priorities and timelines
  • Strong communication skills, both oral and written
  • Ability to work independently and in teams
  • Attention to detail

 

Benefits

  • Pension scheme
  • Private medical insurance
  • Other voluntary benefits include: Childcare Vouchers, Bike to Work

 

While there is a strong preference for the position to be based in our head office in Scotland, a base in our Chertsey office in Surrey could be considered for an extremely experienced and autonomous candidate. 

 

Kyowa Kirin International is an equal opportunities employer.

Apply for this job: Regulatory Operations Associate

Contact Information:

Address:  Head Office
Galabank Business Park, Galashiels , Selkirkshire
TD1 1QH
Scotland
Tel:  +44 1896 664000
Website:  Visit Our Web Site

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