(Associate) Director of Regulatory Affairs

Posted 1 month ago
£90,000 - £125,000 per year
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Job Description

(Associate) Director of Regulatory Affairs

AL Solutions are searching for an (Associate) Director of Regulatory Affairs to join a med-sized CRO, based in Germany. This is an opportunity to take a leadership position, responsible for strategic improvements and growth.

As the (Associate) Director for the Regulatory Affairs department, you will represent the business unit both to internal stakeholders and external clients, supporting the company’s growth and development. This role includes direct line management, including hiring, cycle of staff management, performance management, talent development, and resourcing.

Responsibilities include:

  • Leadership in terms of regulatory submissions
  • Ensuring quality and timelines of Regulatory deliverables
  • Assume responsibility for process definition and compliance relating to functional areas (SOPs, Working instructions etc)
  • Main POC for clients and partner CROs
  • Develop country regulatory intelligence data related to clinical study application
  • Support the company in scope of new business opportunities and attend the bid defence meetings
  • Support junior members of the team
  • Act as a role model for the regulatory function
  • May take on the regulatory lead responsibilities for certain projects
  • Line management (6-10 people team)

Requirements include:

  • BSc in a scientific or technical discipline
  • Extensive experience within Regulatory Affairs within a Pharma or CRO
  • In depth knowledge of ICH/GCP guidelines, national and international regulatory requirements, EU regulations and SOPs
  • Strong clinical trial registration process understanding
  • Team leader attributes

Please apply to find out more. Alternatively, visit the AL Solutions website for more opportunities within the Life Science sector.