Regulatory Co-ordination Manager -1 year Contract Role -Home working available

Employer
Advanced Regulatory (UK & Europe)
Location
The Netherlands
Salary
Competitive
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Contract
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Regulatory Co-ordination Manager - 1 year Contract Role - Home working available

Location: Based in the Netherlands commutable from Amsterdam, Leiden, Haarlem, The Hague, Rotterdam, Gouda

My client is a global Biotechnology company with strong sales and a great company culture focused on innovation and personal development for all.  They are currently expanding their EU and global regulatory function and have a requirement for a motivated regulatory professional to join the team as a Regulatory Business Process Co-ordinator / Manager.

You will play a key role in defining and supporting the submission portfolio management process across multiple products and therapeutic areas with interaction with Snr RA Project Managers and Regulatory Line Managers for a variety of sometimes complex and diverse challenges with decision-making that impacts multiple projects. As a Business Process Coordinator your focus is on the EMEA region; but you will liaise with global colleagues, senior management and Global Project Teams.

Projects are varied and will include hands-on involvement in the interpretation of health authority regulations, product change control activities, Labeling/labelling changes, submission publishing/dispatch and/or registration tracking.  You will manage multiple projects and accurately document change and ensure all approval requirements are met before releasing product quality, patient safety, and in some cases, product sales.

Personal experience/qualifications needed

  • Bachelor’s degree (scientific discipline preferred)
  • Familiarity with one or more key regional Health Authority regulations, interpreting regulatory guidance and monitoring the external regulatory environment for changes that impact submission standards or other regulatory practices
  • Experience with eCTD, NEES and other technical submission formats
  • Experience with one or more European procedure types, e.g. CP, MRP/DCP
  • Experience with lifecycle maintenance, submission management and document management concepts
  • At least 4 years of previous industry experience within Regulatory Affairs, or Regulatory Operations.

Please note if this role isn’t for you but you know someone who might like this role, we offer a great referral bonus for any of your friends or colleagues that we help to find a new role!

 

To Apply!

To apply, please send a full CV to CV@AdvTalent.com, or contact Theo Moore on +44 (0)207 801 3384. We are assigned these roles by our client and will provide you with support throughout the hiring process.

About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

Contact us today to see how we can help you make that next career move on

+44 (0)207 801 3380

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-pharmaceutical community.

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8 Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +44 (0)20 7801 3380
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