Skip to main content

This job has expired

Regulatory Affairs Manager

Employer
i-Pharm Consulting
Location
London, Uxbridge, England
Salary
Negotiable
Start date
26 Jul 2021
Closing date
9 Aug 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Job Details

Regulatory Affairs Manager

12 month contract

Home based

Global biopharmaceutical company - Sitting in UK & Ireland team

£58.08 per hour pay rate

Description

The Regulatory Affairs Manager will support one or more products from a regional regulatory perspective. The purpose of this role is to ensure that our client acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products and to ensure timely regulatory compliance with above approvals in the UK.

Key responsibilities include:


  • Advising the GRT on regional regulatory considerations in developing strategy
    * Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
    * Under general supervision, planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements.
    * Under general supervision, developing and/or implementing innovative and compelling regulatory strategies designed to enable patient access, following regulatory affairs processes and activity planning in accordance with national legislation and regional regulatory requirements.
    * Under general supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
    * Leading development of regional regulatory documents and meetings in accordance with the regulatory strategy
    * Providing regulatory direction on regional regulatory mechanisms to optimize product development
    * Directing the development of the regional product label by collaborating with internal stakeholders to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
    * Managing regional label negotiation activities
    * Identifying and mitigating regulatory risks and support contingency planning
    * Acting as a contact with MHRA in fulfilling local obligations by product assignment

    Knowledge and Skills:

  • 4-5 years of Regulatory experience concerning UK licenses - including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
    * Ability to anticipate regulatory agency responses to strategy
    * Awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
    * Experience with UK and national legislation and regulations relating to medicinal products
    * Ability to understand and communicate scientific/clinical information
    * Cultural awareness and sensitivity to achieve results across both regional country and International borders.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert