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Regulatory Affairs - Regulatory Affairs Manager Jobs - Berkshire

Regulatory Affairs - Regulatory Affairs Manager Jobs - Berkshire (Job Ref: WR/JOBS/26207-12691)

Job Description :

Flame Pharma - Regulatory Affairs - Regulatory Affairs Manager Job - Berkshire:

UK, Berkshire: Excellent Package

Do you have extensive experience of global clinical trials? Do you have line management or supervisory experience and want to work with a global CRO?

We are working with an international full service Clinical Research Organisation to recruit their full range of clinical opportunities. With a worldwide presence, and experience across a wide range of clinical therapeutic areas, our client can offer the career you are looking for within Regulatory Affairs.

Job Title

Regulatory Affairs Manager

Background

Reporting to the Associate Director Regulatory Affairs, the Regulatory Affairs Manager will provide regulatory affairs advice and support for key company projects plus assist with the management of the regulatory affairs and Technical Writing division. A large part of the job will be providing strategic regulatory advice on clinical development plans and assisting the Senior Regulatory Affairs Specialist to develop new business opportunities for the regulatory affairs department.

Key Responsibilities

• Produces global clinical trial applications, clinical study reports, publications and summary documents.
• Produces expert reports, investigator brochures, and supporting regulatory documentation
• Acts as the RAPM for designated complex projects and manages the regulatory aspects of the project.
• Ability to provide strategic regulatory advice to clients on their proposed clinical development plan.
• Assists in the management of projects in line with budgets and agreed timelines to achieve client satisfaction.
• Sources appropriate data, information and documentation from clients and/or their nominees to fulfill regulatory requirements.
• In conjunction with regulatory affairs Management, creates and maintains regulatory templates for all types of submissions as well as specific project tracking systems incorporating all relevant information.
• Acts as line Manager for assigned RATW staff by monitoring their workload and ultimately motivating them to be efficient and proactive.

Qualifications and Experience

• Demonstrates an excellent knowledge of ICH-GCP and global regulatory guidance. 
• Demonstrates ability to develop and maintain a regulatory affairs contact network.
• Demonstrates a good knowledge of clinical trials methodology.
• Demonstrates a working knowledge of protocols and indications being studied.
• Demonstrates a working knowledge of Regulatory Guidelines and where to find these
• Demonstrates an excellent understanding of potential project related problems and resolution options. 
• Resolves project related problems and prioritises workload to meet deadlines with minimal support from management.
• Demonstrates superior ability to collect, interpret and use regulatory data. 
• Demonstrates superior understanding of the role of Regulatory Affairs within the product life cycle from conception to approval.
• Creates Regulatory submissions to a superior standard.
• Motivates other members of the project team to meet timelines and project goals. 
• Demonstrates superior communication interpersonal skills.
• Exhibits excellent mentoring skills

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary in the region of 40000-50000 plus bi-annual bonus scheme.

Key Words

Regulatory Affairs, Manager, Clinical Research, Clinical Trials, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

This position is based in Berkshire. For more information and to apply for this position, please contact Flame Pharma on 0800 085 0858.