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Regulatory Science Director

2 months ago

Leeds, Leeds, United Kingdom DNA Life Sciences Full time
Key Responsibilities:

As a key member of our team at DNA Life Sciences, you will be responsible for overseeing and planning all regulatory activities across our product portfolio. This includes acting as a key regulatory contact and interface with internal and external cross-functional teams, developing Request for Proposals and defining the scope of services for outsourced regulatory activities, and managing the assessment and selection of external regulatory providers.

Key Skills and Attributes:
  • Minimum of a Bachelor's degree in a life science, medical, or related field.
  • 8+ years of regulatory experience.
  • Excellent 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, with experience of overseeing regulatory external providers.
  • Demonstrated ability to liaise with key regulatory bodies and have a comprehensive understanding of developing guidelines and regulatory trends.
What We Offer:

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced regulatory professional looking for a new challenge, we encourage you to apply for this exciting opportunity.