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Clinical Regulatory Affairs Manager - will consider a PM that wants to progress

Employer
Mosaic Regulatory Solutions
Location
East Midlands Region
Salary
Excellent
Start date
4 Apr 2019
Closing date
4 May 2019

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

Job Details

Senior Regulatory Affairs Manager. In this role, you will act as Regulatory Lead in providing a centralised service coordinating regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) for clinical studies 

As the Senior Regulatory Affairs Manager, you will line manage members of the Regulatory Affairs Department, drive continuous quality improvement relating to regulatory processes.

Main tasks and responsibilities include:

  • Acting as Regulatory Lead for clinical studies with responsibility for timely delivery of regulatory submissions (CTA, REC & ARSAC) as agreed with study sponsors
  • Leading and co-ordinating, authoring, compiling and submitting CTA applications and post-submission activities
  • Leading / overseeing REC submissions and post-submission activities
  • Leading / overseeing preparation of ARSAC applications and maintenance activities
  • Reviewing  and sponsor documentation required for CTA applications and REC submissions and providing strategic advice to project teams and sponsors
  • Acting as point of contact for Regulatory Authorities, RECs and ARSAC with regards to submissions
  • Liaising with and negotiating innovative and practical solutions to comments arising from Regulatory Authorities, RECs and ARSAC
  • Inputting into and management of continuous quality improvement initiatives relating to regulatory submissions, Ethics and ARSAC submission processes

The Candidate

The successful candidate will be educated to a minimum degree level in a biological or life science discipline, coupled with substantial previous regulatory experience in a similar role in a pharmaceutical company or CRO. Experience of US IND and eCTD submissions is also desirable although not essential.

Other skills and experience required:

  • Possess detailed knowledge of relevant regulations & guidance and ability to critically analyse and apply knowledge to develop innovative regulatory solutions to arising issues
  • Proven project leadership and team work ability
  • Ability to juggle a range of tasks/ issues simultaneously
  • Ability to work to strict and tight deadlines
  • Possess high quality standards and attention to detail
  • Be a confident and articulate communicator (both written and verbal), with the ability to convey and present highly complex information to others clearly and logically
  • Demonstration of effective communication with regulatory authorities
  • Being customer focused and ability to respond to sponsor requirements
  • Experience of effective line management

Company benefits:

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

Company

Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.

Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.

We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.

Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.

Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.

Company info
Website
Telephone
07951 082482
Location
Blackheath
London
SE3
GB

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