Regulatory Clinical Development Consultant

Proclinical are recruiting a Regulatory Clinical Development Consultant for a consultancy. This role is on a contract basis with the ability to work remotely from anywhere in the UK.

Responsibilities:

• Guide multi-jurisdiction programs of work and distribute consulting services in your respective area of knowledge.
• Provide assistance and advice across a variety of regulatory actions.
• Supply technical guidance to any other members of the company's consultancy team, which involves any other principal and senior consultants.
• Assist with the development and operation of the alliance network and new partnership prospects.
• Form and uphold a high level of technical knowledge within the area of product development and global regulatory affairs.
• Serve as a representative for the company's clients in regulatory agency engagements and offer regulatory solutions to agency objections.
• Guarantee delivery of project objectives within approved timelines, upholding oversight of project budgets, etc.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• At least 15 years of experience in drug development, with at least 5 years of experience within biotechnology and regulatory affairs.
• Familiarity within clinical development across a variety of therapeutic indications/illness areas.
• Acquaintance with drug development covering Europe, the UK and the US.
• Capable of outlining and distributing creative scientifically driven solutions to technical development and regulatory concerns.
• Prior involvement in offering tactical regulatory planning for the delivery of industry development objectives, up to marketing authorisation.
• Familiarity with deliberating with multi-national regulatory authorities which at least involves the European, the UK and the US authorities.
• Able to distribute education through scientific conference presentations in chosen area and training of junior personnel.
• Fluency in the English language.
• Computer literacy.
• Capable of presenting self in a professional manner.
• Works well independently and takes the initiative.
• Able to balance priorities and completing tasks to their deadlines.
• An organised individual with a high attention to detail.
• Communication skills both verbally and in writing.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or p.duvall@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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