Regulatory Principal Consultant

Clinical Professionals Limited
12 Apr 2018
19 Apr 2018
Contract Type
Full Time

Regulatory Principal Consultant
Hertfordshire ( Home based and Flexible working is an option)

Due to an increase in demand for services, a well-respected and forward thinking Regulatory affairs consultancy are looking to recruit a Regulatory Principal Consultant.

Reporting in to Director level, this role will see the successful incumbent take responsibility for a portfolio of projects and a complete team of regulatory professionals. This includes projects in Clinical Development, MAA filling stage and Post Approval lifecycle management.

Providing regulatory strategic advice to clients on Guidelines, legislations and procedures, within assigned projects,
Develop regulatory plans to meet project and client goals,
Prepare Regulatory submissions, clinical trial applications and scientific advice requests, PIPs, MAA dossiers and variations
Manage regulatory approval procedures at both national and EU level,
Lead regulatory projects, ensuring direct liaison and negotiation with Reg. authorities.
Analyse regulatory impact on Project and business plans

About You:
Possess working knowledge of scientific and regulatory environments, you will have 10 years experience within EU regulatory affairs
Analytical outlook, you will need to analyse current and future trends within Reg
Life Sciences or Pharmacy degree
Team Management experience, you will be responsible for coaching and mentoring others
Experience applying regulatory and Scientific knowledge to solve complex problems and situations
Experience developing clear and effective regulatory strategies to align and meet business needs
Customer centric, you will be developing client and cross business relationships
Full UK driving licence

Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then youll receive 250 worth of vouchers of your choice.

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