EMEA Regulatory Professional job in Cambridge, England

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Project Manager

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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

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