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Job Details

Regulatory Affairs Director

Company: Umbilical Life
Location:
Reference: MATT/RADIR
Closing Date: 09 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Matt Law of Umbilical Life is excited to be recruiting for a Director of Regulatory Affairs

Requirements:

Responsibilities and Duties

General Responsibilities and duties of organisation:

  • To write, review & submit clinical trial applications and associated documentation (incl. IMPDs, IBs)
  • Strategy & Development of products, from early stage to Post-marketing
  • Write and compile MAAs – Modules 1-5 (as applicable)
  • To write or review all types of simple & complex variations
  • Write and review SOPs/processes
  • Write and/or review sections of dossiers for Centralised/Decentralised procedures
  • Project Management of all regulatory requirements

Key Responsibilities and duties of role:

  • To be a client lead
  • Expert regulatory documentation author (IMPDs/INDs)
  • Provide leadership in scientific advice meetings at national agencies and EMA
  • Lead EMA procedures including orphan applications, PIPs and MAAs
  • Point of contact for agency interaction
  • Provide expert EU regulatory strategy
  • Project management/lead responsibilities
  • Client facing with strong communication skills, willing to travel

Qualifications and Skills

Professional Experience

  • 2:1 (or above) graduate in relevant scientific discipline
  • 5+ years broad & deep European regulatory affairs experience
  • Strong understanding of the regulatory environment including guidelines
  • Ability to lead team members in a matrix management environment
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Excellent computer skills

 

 

Apply for this job: Regulatory Affairs Director

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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