Regulatory Affairs Leaders For Wellfunded Biotech Startup

Job Details:

RBW are recruiting on behalf of cutting-edge biotech, who are set to revolutionize the vaccine sector. They are building a groundbreaking platform to deliver better mRNA vaccines and treatments for various diseases including cancer, COVID and flu, improving equity of accessibility to these life-saving drugs.

At a key growth point in their development, they are now seeking a permanent Regulatory Affairs Leader to join the team, based in their offices in Didcot.

This is an incredible opportunity for an experienced regulatory professional to build and take ownership of the function. Reporting directly to the CEO, the Regulatory Affairs Leader will carry out the regulatory activities in preparation for their First In Human trails, and give ongoing support for global regulatory requirements and registrations towards commercialization.

Key Responsibilities:

  • Work on complex and dynamic clinical trial projects or programs (mRNA-LNP vaccines).
  • Review core scientific documentation and feedback gap analysis administratively and technically/scientifically, both internally and to CRO/CDMOs.
  • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications.
  • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters.
  • Track the regulatory project documentation flow.
  • Prepare and maintain core clinical trial dossiers in accordance with applicable regulatory requirements.
  • Write scientific documents e.g., Investigational Medicinal Product Dossier (IMPD), Investigator’s Brochure, clinical trial justifications with support of QC/QA Manager.
  • Interact with internal and external clients to provide regulatory guidance and strategic input for clinical trials.
  • Provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs).
  • Ensure accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs.
  • Writing new SOPs with support of QC/QA Manager.
  • Deliver regulatory training/presentations as required.

Essential Experience and Skills:

  • Minimum undergraduate degree educated in relevant field.
  • Experience in regulatory affairs, ideally in vaccine field, but other biologics or combination device experience will be considered
  • Familiarity with MHRA regulations
  • In-depth working knowledge and understanding of the principles of GCP
  • Understanding of the regulations, directives and guidance supporting clinical Research and Development.
  • Exceptional interpersonal, negotiation, and facilitation skills.
  • Demonstrates strong analytical and problem-solving capabilities.
  • Excellent verbal and written communication.
  • Strong software and computer skills, including MS Office applications.
  • Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision.
  • Functions well both autonomously and in a multi-disciplinary team, in a high-paced, dynamic environment.

What’s on offer:

  • Hybrid work- three days in office, two from home
  • Job title can be flexible based on candidate expectation
  • Visa sponsorship is possible for the ideal candidate
  • Healthcare
  • Dental
  • Discretionary bonus
  • £80,0000 – £120,000 DOE

This is a rare career-changing position, and a lot of interest is expected, so please apply today or contact or +441273 952176 for more information

Job Category: Others
Job Type: Full Time
Job Location: England

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