job details for:
Clinical Research - Principal Regulatory Consultant Jobs - Cambridgeshire

Clinical Research - Principal Regulatory Consultant Jobs - Cambridgeshire (Job Ref: WR/JOBS/24884-11369)

Job Description :

Job Summary

Flame Pharma Regulatory Affairs – Principal Regulatory Consultant – Ely, Cambridge

UK:  Salary up to £50k

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 bio pharmaceutical industry. As the Principal Regulatory Consultant you will be responsible for providing advice and assistance to clients and other associates in their areas of expertise. You will work closely with the Assistant Directors providing regulatory strategic input for the pharmaceutical sponsors and support new business development whilst managing a specialist project.

The Role

Reporting to the Director of Regulatory Affairs you will be accountable for performance on major projects, whilst working independently assisting clients with regulatory advice and strategies & follow company standards/policy within OU. Whilst you provide general, development and regulatory advice to both clients and associates you will be responsible for leading designated projects and direction of team members to complete projects on time, to both cost and quality requirements (including QC of documentation as necessary)., you will act as a primary point of contact for specific clients and regulatory authorities as required. You will arrange, lead and report on client meetings, & meetings with regulatory authorities.

The Person

You will be a senior regulatory affairs professional with have extensive direct regulatory experience & Previous experience as a been at Senior Regulatory Affairs Consultant / Project Manager level or equivalent. Having Membership of TOPRA and other relevant professional bodies you will also have Sound and current regulatory knowledge, with an understanding of the critical path of pharmaceutical product development. With an In depth knowledge of speciality or broad general knowledge of registration and competence in all aspects of dossier production (QSE), you will be able to work independently on several concurrent projects with differing requirements offering attention to detail, flexibility with excellent organisational, verbal and written communication skills.

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