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Senior Associate - Regulatory Affairs

Employer
i-Pharm Consulting
Location
England, London
Salary
Negotiable
Start date
7 Sep 2020
Closing date
21 Sep 2020

View more

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

Job Details

Senior Associate Regulatory Affairs

12 Month Contract

1.0 FTE

Uxbridge - UK

Please note International relocations will not be considered for this role

Job Description

The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)

Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead

Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications

Review regional component of the Global Regulatory Plan and provide input to operational deliverables

Ensure compliance via timely submissions to regulatory agencies

Support RRL in review of promotional materials for commercial activities (ex-US)

Collaborate with CRO�s / partners to support site initiation

Coordinate collection of functional documents in support of regulatory applications

As appropriate participate in GRT to support execution of regulatory strategy

Coordinate QC of regulatory documentation (e.g. briefing packages)

Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)

Prepare regulatory packages and cross-reference letters to support investigator initiated studies

Complete regulatory forms to support agency communications (E.G. EudraCT,)

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

Assist in template development and maintenance

Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams

Actively support regulatory compliance

Support the development and execution of GRT goals

Key Skills

At least 3 years of experience in a Regulatory Affairs role in Pharmaceutical industry

Must have Regulatory Affairs experience concerning CTA's and MAA's

Strong communication skills - oral and written

Organizational skills

Understanding of drug development process

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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