EMEA Regulatory Professional

Highly Competitive
  1. Permanent
  2. Project Manager
  3. United Kingdom
Cambridge, England
Posting date: 25 Jan 2021
35253

A vacancy has arisen for an experienced Regulatory Affairs professional, to take on the role as EMEA Regulatory Affairs Professional who can support the regional regulatory strategy for products in the oncology pipeline. They will be expected to use their previous knowledge to drive forward the regulatory team.

Job Responsibilities

  • Participate in global regulatory team meetings as appropriate
  • Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
  • Act as back-up for contact with Regulatory Agencies as needed
  • Draft cover letters for Regulatory Agency communication
  • Assist in the preparation of meetings with Regulatory Agencies
  • Liaise with LOCs, track and respond to queries in a timely manner
  • Assist in development of processes related to regulatory submissions
  • Draft and review some document content (depending on level of regulatory knowledge / expertise)
  • Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
  • Review protocols and ensure alignment with regulatory requirements
  • Advise team on required documents and submission strategies in preparation of CTAs
  • Ensure CTA submission packages are complete and available according to agreed timelines
  • Provide regulatory support throughout registration process
  • Provide regulatory support throughout life-cycle management
  • Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
  • Assist with submission and acceptance of MAA
  • Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans

Skills and Requirements

  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
  • Experience in regulatory affairs
  • Teamwork experience
  • Project management skills
  • Oral & written communication skills
  • Knowledge of the regulatory environment, guidelines and practice of EMEA regions

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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