Senior Associate - Regulatory Affairs

Employer
i-Pharm Consulting
Location
England, London
Salary
Negotiable
Closing date
28 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
You need to sign in or create an account to save a job.

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

Life Sciences recruitment is what we do.

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

 

Our clients include many of the most successful and innovative Pharmaceutical, Biotechnology, and Medical Devices companies, as well as a range of Contract Research & Manufacturing Organisations, Healthcare Agencies and Consultancies.

 

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.

Contact Us
  • 212 New King’s Road
  • London
  • SW6 4NZ
  • GB
  • +44 (0) 20 3189 2299
You need to sign in or create an account to save a job.

Get job alerts

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

Create alert

Similar Jobs