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Regulatory Affairs - Regulatory Affairs Specialist Jobs - Berkshire

Regulatory Affairs - Regulatory Affairs Specialist Jobs - Berkshire (Job Ref: WR/JOBS/23600-9887)

Job Description :

Flame Pharma - Regulatory Affairs – Regulatory Affairs Specialist Job - Berkshire:

Job Summary

Do you have extensive Regulatory Affairs experience with the ability to interpret CMC, preclinical and clinical data?  Have you been involved in strategic development 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.

Reporting to the Senior Regulatory Affairs Specialist, the Regulatory Affairs Specialist will provide regulatory affairs advice and support for key company projects plus assist with the management of regulatory affairs 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.

Job Title

Regulatory Affairs Specialist

Background

Reporting to the Senior Regulatory Affairs Specialist, the Regulatory Affairs Specialist will provide regulatory affairs advice and support for key company projects plus assist with the management of regulatory affairs 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.
• Ability to provide strategic regulatory advice to clients on their proposed clinical development plan.
• Able to assess CMC, preclinical and clinical data for NCEs, biotechnology and other therapies.
• 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.
• Supports regulatory affairs management in ensuring departmental awareness and compliance of current local, national, regional and harmonised guidance and requirements for the format, content and control of all types of regulatory procedures and submissions.
• In conjunction with regulatory affairs Management, creates and maintains specific project tracking systems incorporating all relevant information.

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 were 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.

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, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in Berkshire.

For further information about this role, please contact Flame Pharma.