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Regulatory Affairs Manager

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JOB OVERVIEW

Our Client is a global Contract Research Organisation (CRO) business. They combine clinical development, early access program, and clinical trial supply capabilities to deliver a unique, seamless service for our international pharma and biotech clients. Their mission is to pioneer the way life-changing medicines are developed and accessed for patients around the world. Their range of services allows to maximise access and generate evidence at every point along the drug development pathway. This enables the company to simultaneously address the immediate and future needs of patients.

Skills Required

Bachelor’s degree in a healthcare/science-related subject

At least 3 years’ experience in a regulatory affairs (preferred), or relevant related role (e.g. clinical operations, medical affairs) within the pharmaceutical medicine environment

Clinical Trial Regulatory experience essential

Proven ability to interpret and apply complex regulations

In-depth knowledge of drug development process and pharmaceutical industry experience

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint

Effective time management skills and ability to manage competing priorities

Excellent communication skills

Knowledge of GDP, PV and GCP

High attention to detail

Medical writing experience, ideally of regulatory dossiers

Sets the highest personal standards

Key skills and experience

  • Provide strategic and operational regulatory expertise and support to Early Access Programs & Clinical Development divisions
  • Be the client point of contact for regulatory activities for multiple scopes and attend regular client calls to provide regulatory updates as required
  • Develop regulatory strategy report at the start of each project
  • Develop own external regulatory network relating to Regulatory Affairs for the purpose of thought leadership, regulatory intelligence and continuous professional development
  • Prepare, submit and manage global clinical trial submissions in EU, UK, US and 3rd markets
  • Support regulatory team on wider consultancy projects (including but not limited to; Scientific Advice, Paediatric Investigation Plan and Orphan Drug Development).
  • Manage and track all regulatory activities relating to set-up, maintenance and close-out of projects
  • Develop key regulatory documents for cohort regulatory submissions including medical writing where required
  • Prepare, collate and submit regulatory packages for cohort regulatory submissions in line with local requirements
  • Develop and maintain regulatory database of global regulations and guidelines
  • Develop and maintain regulatory SOPs
  • Support business development process as required through provision of regulatory expertise
  • Work closely with management team to develop the regulatory function
  • Work closely with wider Bionical-Emas Regulatory department to share learnings and to provide Reg expertise as required
  • Contribute to financial forecasting and invoicing activities for the Department

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