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Director, Regulatory Science

The Director of Regulatory Science will lead the development and execution of global regulatory activities across Biodexa Pharmaceutical’s development portfolio, reporting to the Chief Medical Officer. Responsible for the planning and implementation of regulatory activities to assist in expeditious development of products whilst maintaining regulatory compliance.

Key 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 and key stakeholders, ensuring key regulatory and department objectives are met
  • Development of Request for Proposals (RFPs) and define scope of services for outsourced regulatory activities
  • Manage the assessment and selection of external regulatory providers including Contract Research Organisations (CROs) and other specialized vendors, seeking input from other internal functional updates and ensuring qualification of vendors in accordance with company SOPs. Oversight of Regulatory external vendors by serving as primary contact, problem resolution and defining Key Performance Metrics
  • 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 (including but not limited to: preparation of global clinical trial applications, supporting scientific advice meetings, overseeing orphan drug designation applications and managing accelerated approval pathways)
  • Co-ordinate responses to questions from Regulatory Agencies and external clients ensuring that documentation is prepared to a high quality and in accordance with agreed deadlines
  • 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. Provide regulatory input into technical change controls in a timely manner.
  • 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
  • Able to research and understand changing regulatory landscapes and apply experienced judgement in the expectations of key regulatory bodies to ensure regulatory compliance
  • Able to think “outside the box” and offer solutions / suggestions
  • Able to prioritise multiple competing tasks
  • Strong scientific background and prior experience in key relevant therapeutic area preferred
  • Effective communication skills and cross functional collaboration skills
  • Ability to work independently and within small teams
  • Self-starter and team player who thrives in a fast-paced environment

Fluent in English, (spoken and written)

Role Requirements

  • Permanent position
  • Full/ Part-time (4-5 days/week)
  • Home-based, UK based (requirement to travel to office in Cardiff, Wales every 4-6 weeks and travel domestically/Internationally as necessary to support development activities )

No recruitment agencies please.

Job Title

Director, Regulatory Science

Reports To

Chief Medical Officer

Location

UK based, requirement to travel to office in Cardiff every 4-6 weeks and potential international travel

How to Apply

To apply for any vacancies listed please submit your CV and a cover letter to: careers@biodexapharma.com