Regulatory Affairs Manager2024-04-02T13:24:31+01:00
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Regulatory Affairs Manager Job Vacancy in High Wycombe, England, UK
Randstad
Are you an experienced Regulatory Affairs Professional? We are recruiting for an EMEA Regulatory Professional to work for a Pharmaceutical client at their site based in High-Wycombe on a contract basis for 12 months initially.
The successful candidate will be able to support the regional regulatory strategy for products in their oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations.
Responsibilities:
Input in development, post-approval and Life cycle management
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 area
Liaison with Regulatory Agencies and Local Operating Companies
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
Clinical Trial Applications (CTA)
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
Review and approve clinical trial supply plans
Marketing Authorization Applications (MAA)
Provide regulatory support throughout registration process
Provide regulatory support throughout life-cycle management
Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
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
Experience:
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
Organization & multi-tasking skills
Knowledge of the regulatory environment, guidelines and practice of EMEA regions
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.