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Regulatory Affairs – Senior Regulatory Affairs Associate Jobs - Berkshire

Regulatory Affairs – Senior Regulatory Affairs Associate Jobs - Berkshire (Job Ref: WR/JOBS/22936-9329)

Job Ref : WR/JOBS/22936-9329
Discipline : Clinical Research/Regulatory Affairs
Contract : Permanent
Salary : £35,000-40,000 p.a.

Vacancy Location : Berkshire View Map

Job Description :

Flame Pharma Regulatory Affairs – Senior Regulatory Affairs Associate Job - Berkshire:

Job Summary

Flame Pharma is recruiting an experienced Senior Regulatory Affairs Associate. 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. If you are looking for the career step from Regulatory Affairs Associate, then we want to hear from you regarding this exciting opportunity.

Reporting to the Associate Director of Regulatory Affairs, the Senior Regulatory Affairs Associate will provide regulatory affairs advice and support for all company projects, plus assist with the management of regulatory affairs and technical writing services. You will provide regulatory advice, support and documentation relating to business activities worldwide ensuring clinical trials are conducted such that subjects’ rights, safety and well being are protected and that the clinical trial data are reliable.

Job Title

Senior Regulatory Affairs Associate

Background

Key Responsibilities

• 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 and ethics procedures and submissions.
• In conjunction with Regulatory Affairs Management, creates and maintains regulatory templates for all types of submissions.
• In conjunction with Regulatory Affairs Management, creates and maintains specific project tracking systems incorporating all relevant information.
• Acts as a contact for and liaises with clients, project managers and other members of project teams to obtain relevant information to fulfill regulatory requirements.
• Maintains a superior awareness and familiarity with the current global Regulatory Affairs environment.
• Maintains specific project tracking systems incorporating all relevant information.
• Liaises with project managers and other members of project teams to fulfill regulatory requirements.
• Generates and reviews reports of regulatory data using appropriate systems.
• Prioritises personal workload in line with agreed project plans.
• Uses appropriate IT and software tools to ensure the correct format and presentation of documents.
• Assembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.
• Follows internal SOPs, specifically those relating to Technical Writing and Regulatory Affairs.
• Assists with the development of SOP’s.
• Achieves appropriate quality standards in all documentation within the timelines dictated by project plans.
• Participates in business development activities.
• Performs other duties as assigned by management.

Qualifications and Experience

• Proven experience within Clinical Trial Regulatory Affairs.
• Must have transferable clinical research experience.
• Demonstrates an excellent knowledge of ICH-GCP, global regulatory guidance and relevant SOPs.
• Demonstrates a good knowledge of clinical trials methodology.
• Demonstrates good understanding of the role of Regulatory Affairs within the product life cycle from conception to approval.

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 35000-40000 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.