Career Level Manager
Proclinical are recruiting a Regulatory Affairs Manager for a pharmaceutical business. This role is on a contract basis and allows for remote-based working within the UK. The client is focused on distributing transformative solutions.
Offer regulatory know-how on procedural and documentation needs as outlines by Health Authorities for allocated deliverable(s).
You will develop, implement and uphold submission distribution plans, submission content plans and actively offering updates to allotted shareholders.
Organise the contributions, preservation, and amendment of PLANIT project designs for allocated projects and highlight unforeseen alterations in resource demand in a timely fashion to the Lead RPM as well as to the line manager.
Manage the submission distribution strategy of all reports and all application types per market and /or region.
Comprehend the regulatory framework which involves regional trends, for numerous types of applications and processes for small and large molecules across all areas.
The ideal candidate will handle GRST & GRET sub-teams, such as Cross functional Submission Delivery teams for major submissions, examples of this are NDA/MAA or major LCM initiative.
Recognised regulatory dangers and mediate extenuations to the Lead Regulatory Project Manager (LRPM) as well as the cross functional team members.
Any other duties may be assigned to the role.Skills & Requirements:
Educated to a degree level within a science or similar field.
General regulatory experience within a biopharmaceutical industry or similar.
Exhaustive know-how in drug development.
Solid project management capabilities.
Leadership abilities which involve possessing experience in directing multi-disciplinary project teams.
Clinical Trial Application (CTA) experience.
Experience handling the first wave Marketing Application and/or LCM submissions.
Familiarity with managing complex regulatory deliverables across projects/products.
Acquaintance with the Business and processes.If you are having difficulty in applying or if you have any questions, please contact Pete Duvall at (phone number removed).
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.