Global Regulatory Affairs - Associate Director - Biological Development

Salary
Competitive
Posted
14 Nov 2018
Closes
14 Dec 2018
Ref
AC/GRAAD/BEL
Contract Type
Permanent

One of the most exciting Biotech groups with key offices in the US and EU are now currently looking to appoint a highly skilled “Global Regulatory Affairs – Associate Director’ to spearhead a number of exciting and challenging projects on a global basis.

In this exciting role, the successful applicant will be a key driver responsible for the Regulatory Affairs Strategy globally predominately for development projects. In addition, the role offers tremendous autonomy; a chance to help others grow and to participate in a group with huge potential on an international basis.

Responsibilities

  • Leadership and development of the RA Strategy on a global basis for development projects
  • Set a strategy with the overall goal of product registration in all global markets.
  • Build strong relationships and advocacy with the regulatory agencies – both at the local, nationally – as well as with notified bodies and international regulatory authorities (FDA & EMA)
  • Manager Scientific meetings and follow up with key global competent authorities
  • Can understand possible areas of Risk and act accordingly on a strategic and operational basis
  • Provide direct support to team colleagues through direct and indirect management
  • Communicate Regulatory plans and progress with all necessary internal and external stakeholders
  • Collaborate with fellow Regulatory colleagues on other aspects in the Regulatory cycle to achieve the common overall goal (CMC team members)
  • Work with other key areas of the business to support strategic development from a Regulatory perspective
  • Ensure all documentation for successful submissions is completed to the required level
  • Participate in the group and support the Executive leader of Regulatory Affairs when required 

 Skills needed

  • Master’s degree in Life sciences area or related field
  • Demonstrated experience working in Regulatory Affairs with Biological products is a must
  • Have a distinct background in Regulatory strategy design for development projects would be preferred but not essential 
  • Must have a demonstrated background dealing with Competent authorities
  • Ideally skilled in managing others 
  • Driven, passionate and motivated
  • Excellent communication skills
  • Can work office based in Belgium

If you feel you match the  qualities we are looking for  and the role appeals to you , please contact Antony Clark at RBW Consulting on +44 1293 584300. Alternatively, please email me at antony.clark@rbwconsulting.com for full details.

At RBW Consulting Ltd, every one of our consultants has the benefit of multiple years’ experience in helping Pharmaceutical & Medical Device Professionals find the right career step for their current and future aspirations. With unrivalled industry knowledge and network in Biotech’s, Pharmaceutical and Medical Device Companies throughout the UK, Switzerland and Europe, we would be delighted to speak with you about the role you are looking for

 

 

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