Regulatory Affairs Associate Director/Director

21 September 2018

AUTHOR: Antony Appleyard

Reports to: Technical Director

Job Description
The Regulatory Affairs Professional provides development stage advice to internal staff and to clients for a broad range of programmes. They will possess a strong understanding of existing and leading-edge technologies, and is able to speak knowledgeably about client programmes. They will provide the following expertise based services:

  • 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
  • To assist the senior management team by providing leadership support to a team of internal consultants and their clients
  • To assist the company in providing regulatory knowledge to business development colleagues during bid defence

Key Responsibilities and Duties

  • Provide world-class advice across a range of product types
  • Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
  • Provide development related strategy for a broad range of programmes
  • Provide advice and dossier support
  • Lead EMA procedures including orphan applications, PIPs and MAAs
  • Provide expert EU regulatory strategy
  • Regulatory lead and point of contact for national agency and EMA interactions
  • Provide direct line management and matrix team based leadership where needed
  • High level of client focus and accountability
  • Assist with Business Development activities by taking part in new prospective client-lead discussions

Professional Experience

  • Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines
  • 5+ years broad & deep European regulatory affairs experience in development stage programmes
  • Demonstrable experience in liaising and negotiating with regulatory authorities
  • Demonstrable experience in orphan applications and PIPs, etc.
  • 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
  • Collaborative approach and able to work effectively with matrix based teams involving internal staff, client teams that include independent consultants
  • Confident speaker about regulatory challenges in the clinical development stage, and able to communicate effective solutions to clients.


  • 5+ years of experience in relevant development stage programmes
  • 7+ years of experience in regulatory affairs based activities and regulatory authority interactions
  • Exposure to MAA dossier writing and submission procedures
  • US FDA facing experience

Personal Attributes

  • Innovative and pragmatic problem solver
  • Attention to detail
  • Strong communicator with the ability to influence
  • Completer-finisher able to provide decisive leadership in a project team setting
  • Ability to provide a flexible, proactive and dedicated approach whilst dealing with clients with different working styles and cultures.
  • Strong client focus