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Senior Associate Regulatory Affairs

Employer
i-Pharm Consulting
Location
Uxbridge, London, England
Salary
Negotiable
Start date
14 Apr 2021
Closing date
28 Apr 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Senior Associate Regulatory Affairs - 30554

1 FTE

£31.07 maximum pay per hour

Sitting in EU Oncology team

12 month contract

Uxbridge site

Description:

The Regulatory Affairs Senior Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects.

Key responsibilities include:


  • Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. CTA package development and submission)
    * Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
    * Coordinate collection of functional documents in support of regulatory applications
    * Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
    * Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
    * Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications
    * As appropriate may participate in CST (Clinical Study Team) and/or GRT (Global Regulatory Team) to support execution of regulatory strategy
    * Respond to specific requests from and communicate relevant issues to CST/GRT
    * Support the development and execution of CST/GRT goals
    * Review regional component of the Global Regulatory Plan and provide input to operational deliverables
    * May support Regional Regulatory Lead in review of promotional materials for commercial activities
    * Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
    * Support process improvement initiatives, standards development, and metrics

    Key Knowledge and Skills include:

  • Relevant experience in Regulatory Affairs, especially regarding Clinical Trial Applications (CTAs) in the EU region.
    * Understanding of drug development process
    * Strong communication skills - oral and written
    * Organizational skills

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

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