Director of Regulatory Strategy

1 week ago

United Kingdom DNA Life Sciences Full time

Responsibilities:

  • Responsible for the oversight and planning of all regulatory activities across the product portfolio.
  • Act as key regulatory contact and interface with internal and external cross functional teams.
  • Development of Request for Proposals and define scope of services for outsourced regulatory activities.
  • Manage the assessment and selection of external regulatory providers.
  • Provision of global regulatory strategic advice and operational support.
  • Responsible for the authoring, review and management of key regulatory documentation for filing to Regulatory Agencies.
  • Assist in the planning and execution of regulatory strategy for successful development of products including input and authoring of development plans and Target Product Profiles.
  • Assist in development of cGMP manufacturing processes and controls and prepare regulatory documentation for GMP inspections.
  • Maintain regulatory document management system and support regulatory compliance including the writing and maintenance of key regulatory SOPs.
  • Support regulatory intelligence activities.

Skills and Attributes:

  • Minimum of a Bachelor’s degree in life science, medical, or related field
  • 8+ years regulatory experience
  • Good knowledge of global regulatory requirements for the development of small molecules and biologics
  • Proven ability in the writing of key regulatory documentation including CTAs, INDs, Scientific Advice requests and development plans
  • Excellent knowledge of GXP across the development functions, ICH guidelines and appropriate regulations
  • Excellent organisational, analytical, planning and project management skills and experience of overseeing regulatory external providers
  • Demonstrated ability to liaise with key regulatory bodies and have comprehensive understanding of developing guidelines and regulatory trends

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