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Job Details

Senior Regulatory Affairs Associate

Company: United BioSource Corporation.
Location: London, United Kingdom
Reference: 1600004F
Closing Date: 08 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package

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Job Summary:

Responsible for the all-electronic and paper assembly, publishing, production, dispatch, logging and archiving of regulatory submissions.Provide project management oversight (tracking, planning, timelines) for regulatory (MOH) submissionsReview submission documents for content and format corrections.Responsible for monitoring inventory of supplies related to submission preparation and initiate purchase orders.May directly interact with regulatory agencies.

Requirements:

Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.

Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.


Brief Description:  The primary responsibility of this role is the creation of regulatory documents and development of regulatory strategy to achieve regulatory approvals and clearances worldwide expediently and consistently within all studies, interventional and non-interventional.
Specific Job Duties:
  • Responsible for the all-electronic and paper assembly, publishing, production, dispatch, logging and archiving of regulatory submissions.
  • Provide project management oversight (tracking, planning, timelines) for regulatory (MOH) submissions
  • Review submission documents for content and format corrections.
  • Responsible for monitoring inventory of supplies related to submission preparation and initiate purchase orders.
  • May directly interact with regulatory agencies.
  • Establish and facilitate document management activities at UBC and with clients that are required to support timely and accurate electronic publishing.
  • Responsible for developing and maintaining Regulatory Operations processes in compliance with health authority requirements, including regulations and guidance documents.
  • Educate teams regarding regulatory submissions procedures.
  • Consult and advise customers on regulatory submissions procedures and best practices.


Requirements:
  • Bachelor degree in life sciences desirable
  • Relevant regulatory / clinical research document management experience in a pharmaceutical company/ CRO.
  • Client focused approach to work and ensure client expectations are managed and met.
  • Experience in resource and timeline management for complex regulatory submissions.
  • Excellent oral, written and presentation skills.
  • Excellent planning and organisational skills.
  • General computer proficiency including Microsoft WORD, Excel, Access, Internet and experience with document tracking tools.
*LI-AF1-UBC
NO AGENCIES PLEASE

Apply for this job: Senior Regulatory Affairs Associate

Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

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