Senior Regulatory Affairs Specialist

2 weeks ago


Hertfordshire, United Kingdom Leaman Life Sciences Full time

We have an exciting opportunity to work for an international organization leading the way in product development and regulatory consulting.


You'd be joining an innovative, well-known company with a breadth of expertise across the regulatory space. As a Senior Consultant/ Specialist, you are responsible for supporting client projects in the realm of 'Clinical Regulatory Activities' please see below for more info:


Responsibilities:

  • Provide strategic, technical, and regulatory advice/services in the area of clinical development of medicinal products, across a wide range of therapeutic areas.
  • Offer support/advice across a broad range of regulatory activities
  • Produce drug development plans, data gap analyses, and international regulatory strategies from a Clinical perspective.
  • Contribute to technical authorship and review of development regulatory documents.
  • Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise
  • Represent in regulatory agency interactions and provide regulatory solutions to agency objections


Requirements:

  • MSc degree or higher in a life sciences
  • 10+ years in drug development and regulatory affairs
  • Expertise in authoring and reviewing of regulatory documents; development regulatory documents; Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications
  • Experience in negotiation with multinational regulatory authorities including, as a minimum, European, UK, as well as US authorities.


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