Regulatory Affairs Consultant

3 weeks ago

Bishop's Stortford Hertfordshire, United Kingdom Hobson Prior International Ltd Full time

Principal Consultant - Clinical (Remote - UK Based)
Hobson Prior is seeking a Principal Clinical Consultant with a strong background in clinical development and regulatory affairs. This role will involve providing strategic, technical, and regulatory advice to clients in the development of human medicinal products across a wide range of therapeutic indications. The successful candidate will also contribute to the authorship and review of regulatory documents and provide leadership within the consultancy team.
For this role you will, provide strategic, technical, and regulatory advice/services to clients in the area of clinical development of human medicinal products.
Offer support and advice across a broad range of regulatory activities.
Contribute to technical authorship and review of development regulatory documents.
Provide technical leadership to other members of the consultancy team.
Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD). Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues.
Experience in negotiation with multinational regulatory authorities including, as a minimum, European, UK and US authorities.
Exemplary verbal communication and presentation skills in English.
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