Regulatory Project Manager

  • Salary: Competitive
  • REF Number: 00034543
  • Consultant: Mary Tilston
  • Contact: 01438 768717
  • Date Published: 01.12.2015
  • Closed Date: 14.03.2016
  • Sector:
  • Location: Belgium,
  • Discipline:

Mary Tilston at CK Clinical is recruiting for a Regulatory Project Manager to join a company in the pharmaceutical industry at their site based in Belgium on a 12 months contract basis.

The main purpose of the role will be to:

  • Be responsible for Global Regulatory Team support and represent Regulatory Program Management at the Global Regulatory Team. You will also translate the regulatory strategy into realistic and executable regulatory deliverables.
  • Support early risk identification and the development of mitigation strategies as well as proactively planning and managing the cross-functional deliverables that support the Global Regulatory Strategy and worldwide submissions (NA, EMEA and APJLA markets) and ensuring the alignment of Regulatory Strategies with functional strategies and the Compound Development Team strategies.
  • Prepare regulatory activities to be discussed in the Global Regulatory Team and work in close collaboration with regulatory liaisons and professionals to work out NA, EMEA and APJLA specific details on HA interactions and submissions.

Further responsibilities will include:

  • Being the single point of contact for Regulatory Project Management activities and managing the regulatory end-to-end process from entry into late development through to launch.
  • Following-up on the progression of all regulatory activities and providing cross-functional leadership to the submission teams in the execution of the finalised pre-submission plan including direct management of Modules 1 and 2.
  • Providing regulatory portfolio oversight, supporting team member planning of short and long term deliverables and informing stakeholders on project deliverables status as well as coordinating the creation, maintenance, management and timely submission of regulatory project budgets.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or higher in life sciences or a related field with significant previous experience of working in Regulatory Affairs within the pharmaceutical/biotech/CRO environment.
  • Experience in Project Management or a professional Project Management certification would be desirable as well as operational knowledge of Project Management systems.
  • Experience with change management and handling conflicting priorities in a changing cross-departmental global environment is required as well as being able to work in ambiguous situations and being creative/flexible to improve working environments.

This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.

For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34543 in all correspondence.

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