Job Ref: 213088381

Date: 2021-01-27 16:09:34

Apply Now

Regulatory Affairs Manager EMEA

Summary of current position to be filled:

A regulatory affairs professional who can support the regional regulatory strategy for products in the oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations.

Job Description

Participate in global regulatory team meetings as appropriate
Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic areas
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
Track dates of submissions and Regulatory Agency responses
Ensure CTA submission packages are complete and available according to agreed timelines
Review and approve clinical trial supply plans
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

Requirements:

Education and experience

University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
Experience in regulatory affairs
Teamwork experienceSkills

Project management skills
Oral & written communication skills
Organization & multi-tasking skills Knowledge

Knowledge of the regulatory environment, guidelines and practice of EMEA regions

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website

Apply Now