ID-Clinical - personnel resourcing specialists for the Pharmaceutical, Biotechnology and Clinical Research industry.
 

ID-Clinical Candidates Job - Principal Consultant


Reference IDSS500103DP
Title Principal Consultant
Description This role is ideal for a highly experienced regulatory professional with the utmost level of technical expertise. In this position you will be responsible for providing advice and assistance to clients and other internal 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.

Responsibilities

Accountable for performance on major projects.
Work independently assisting clients with regulatory advice and strategies.
Follow company standards/policy within OU.
Provide general, development and regulatory advice to both clients and internal associates.
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).
Act as primary point of contact for specific clients and regulatory authorities as required.
Arrange, lead and report on client meetings.
Arrange, lead and report on meetings with regulatory authorities.
Refine area of special skill; provide an in-house resource in specific area of experience.
Contribute to time and cost estimates for projects.
Assist in training staff within OU and the company globally as required.

Skills & Attributes

Relevant scientific degree with extensive direct regulatory experience. Previous experience as a been at Senior Regulatory Affairs Consultant / Project Manager level or equivalent.
Membership of TOPRA and other relevant professional bodies.
Sound and current regulatory knowledge, with an understanding of the critical path of pharmaceutical product development.
In depth knowledge of specialty or broad general knowledge of registration and competence in all aspects of dossier production (QSE).
Able to work independently on several concurrent projects with differing requirements.
Attention to detail, flexibility with excellent organisational, verbal and written communication skills.
Able to interact effectively with designated clients, and with staff from within the company as required.
Salary Excellent package offered
Location Europe, UK, Berkshire
Contact david.proudfoot@id-ss.com

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