Scientific
Scientific

Regulatory Specialist - Maidenhead

Scope

Our client is a high profile research-driven pharmaceutical company who are looking for a Regulatory Specialist which will be rewarded with generous incentives and benefits. You will provide global regulatory expertise for clinical trials. With an office based in Maidenhead, this role offers a flexible, hybrid working schedule.

Responsibilities

  • Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
  • Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
  • Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
  • Monitor key project milestones (actual vs. planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.
  • Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
  • Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
  • Provide technical support on document preparation e.g. Excel spreadsheets, Power Point presentations.
  • Provide operational support for the CTS Team as required.
  • Comply with the company‚Äôs policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the business.

About You

  • At least 2-years CTA experience, preferably in global clinical trial submissions to regulatory agencies.
  • Experience working effectively across cultures and in a complex matrix environment
  • Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.
  • Proactive verbal and written communication style at all levels.
  • Ability to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites
  • Has critical reasoning skills including the identification and resolution of complex problems and/or elevation of issues to relevant line functions and management.
  • Strong Project Management skills, able to manage multiple activities
If you are interested in the above role then please apply or get in touch to discuss further.
Jak Thompson Managed by Jak Thompson
highlights
South East
Permanent
Scientific
apply Posted - 18.07.2022

Apply Now

Allowed files: Word, pdf and txt

Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.