job details for:
Clinical Research - Senior Clinical Trial Regulatory Consultant Jobs - Lothian

Clinical Research - Senior Clinical Trial Regulatory Consultant Jobs - Lothian (Job Ref: WR/JOBS/24885-11370)

Job Description :

Flame Pharma Regulatory Affairs – Senior Clinical Trial Regulatory Consultant Job – Edinburgh or Glasgow:

Job Summary

UK:  Salary up to £40k

Flame Pharma is working alongside a global clinical research organisation providing the full range of early–to-late–stage clinical development services for the world’s biopharmaceutical industry. As the Senior Clinical Trial Regulatory Consultant you are responsible for providing advice and assistance to clients and other associates in your areas of expertise. You will work with the Associate Directors on technical issues and support new business development.

The Role

Reporting to the head of Clinical Trial Regulatory you will be accountable for performance on major projects & prepare Regulatory Submissions and mentor other staff on these tasks. You will work independently and with Principal Consultants and Project Managers assisting clients with regulatory advice and strategies & follow company standards/policy within OU. You will be responsible for completion of assignments on time to cost and quality requirements, with a proactive approach to assignments & contribute to time and cost estimates for projects. With you as a primary point of contact for specific clients and regulatory authorities as required you will develop an area of special skill and provide an in-house resource. In this role you will arrange, participate and report on client meetings with managerial input & participate in and report on meetings with regulatory authorities, with managerial supervision.

The Person

You will be a senior regulatory affairs professional with direct clinical trial regulatory experience, sound and current regulatory knowledge, with an understanding of the critical path of pharmaceutical product development. With your in depth knowledge of clinical trial application process and an understanding of other regulatory submissions you will be able to work independently on several concurrent projects with differing requirements.  With your attention to detail, flexibility with excellent organisational, verbal and written communication skills you will be able to interact effectively with designated clients and with staff as required. 

Key Words

Regulatory Affairs, Senior Regulatory Affairs Consultant, Pharmacovigilance, Drug Safety, Director, Manager, Management, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Hertfordshire, Job, Recruitment