Regulatory Affairs Specialist
: Job Details :


Company : ICON


Job Location : Central London, London, UK


Posted on : 2021-01-14T09:11:36Z


Job Description :

Regulatory Affairs Specialist - office based Marlow, Dublin, Eastleigh or remote based

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Oversight of regulatory submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required.

Roles and Responsibilities:
  • Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
  • Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
  • Maintain a strong customer service management approach with clients.
  • Lead project teams and advise departments on regulatory standards issues and strategiesDevelop, write, and implement standards and procedures related to regulatory operations.Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required
  • Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
  • Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
  • Completing other appropriate duties as assigned by line manager that require similar skills Requirements

    Experience in eCTD, NeeS, Paper Submissions.

    Experiencein EU, US and Canada HA submissions.

    Experiencein Lorenz Docubridge and ISI Tool Box

    Experiencein sequence building and document level publishing

    Good knowledge on the CTD sections.

    Benefits of Working in ICONICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly, what set us apart. Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people, as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

    ICON is an equal opportunity employer -M/F/D/V and committed to providing a workplace free of any discrimination or harassment.F

    rom a small team of 5 people in 1990, ICON now employs over 13,600 people across 89 offices in 37 countries. We have mainly grown organically, but have bolstered our growth through a number of strategic acquisitions, which have broadened our service portfolio and have added scale to existing services. To know more about us visit www.iconplc.com



Similar Jobs (256)

Hobson Prior - Uxbridge, Greater London

Employment Type : Full-Time

Hobson Prior are looking for a Senior Associate Regulatory Affairs to join a leading biotech organisation who provide... and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development...

Posted on : Sun, 17 Jan 2021 08:19:47 GMT

Apply Now!

CHASE - West London

Employment Type : Full-Time

Medical Director - Specialist Female Health - West London Our client is a European innovation-driven speciality... Director who will work closely with the UK General Manager, managing their Medical Affairs team. Sitting on the Leadership Team...

Posted on : Sat, 16 Jan 2021 08:35:27 GMT

Apply Now!


Proclinical Staffing - Berkshire

Employment Type : Full-Time

A spectacular opportunity has arisen for an Associate Director Regulatory Affairs for a Global Biotech remotely. The... strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally...

Posted on : Fri, 15 Jan 2021 08:55:49 GMT

Apply Now!

Fairfax Management Consultants Limited - South East England

Employment Type : Full-Time

are looking for a Regulatory Affairs Specialist for their Advanced Wound Care division. The company Our client are a global medical...Do you want to work for a well-respected medical devices company? Are you experienced in regulatory affairs...

Posted on : Wed, 20 Jan 2021 08:56:24 GMT

Apply Now!

Park Street People - West London

Employment Type : Full-Time

- Regulatory Affairs to join their team. As a UK regulatory affairs specialist, you will take ownership of the relationship... with MHRA, you will be part of the strategy team looking to develop UK regulatory in the post Brexit marketplace...

Posted on : Wed, 20 Jan 2021 08:41:25 GMT

Apply Now!

WorldFirst - London

Employment Type : Full-Time

but not necessary. Well-versed in KYC, AML and regulatory processes. Active interest in current affairs, eager to learn about economic... specialist individuals span across 8 global offices, helping over 250,000 customers worldwide receive outstanding product...

Posted on : Thu, 07 Jan 2021 06:34:33 GMT

Apply Now!

CooperVision - Fareham, Hampshire

Employment Type : Full-Time

JOB TITLE: Senior Regulatory Affairs Specialist LOCATION: Delta Park, Segensworth, Hampshire UK The Senior... Regulatory Affairs Specialist will provide Regulatory support and direction to products from concept to launch. The Sr. RA...

Posted on : Sat, 16 Jan 2021 08:58:01 GMT

Apply Now!

Worldwide Clinical Trials - Nottingham

Employment Type : Full-Time

Requisition Number: 1399 Position Title: Specialist, Regulatory Affairs External Description: SUMMARY: Subject... Affairs department Be or become an established and recognized subject matter expert on regulatory affairs Provide advice...

Posted on : Sun, 17 Jan 2021 01:38:58 GMT

Apply Now!


Regulatory Affairs Specialist Jobs 2020, ICON Jobs Near Me, Jobs in ICON Company, Regulatory Affairs Specialist Jobs Near Me, Jobs in Central London, London, UK. If you are looking for these jobs, click this button!



Disclaimer :This job is posted by the company : ICON, and is aggregated from various online sources and displayed on this page. Our motto is to provide jobs to as many people as we can. For more details : contact@amazejobs.co