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Regulatory Affairs Manager / Senior Manager

Employer
i-Pharm Consulting
Location
London, England
Salary
£45000 - £65000 per annum + competitive benefits
Start date
11 Jan 2021
Closing date
25 Jan 2021

View more

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

Job Details

Regulatory Affairs Manager or Senior Manager

My client, a full-service clinical contract research organization (CRO) is looking to to expand their Regulatory Affairs team with the addition of a Regulatory Affairs Manager. They provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

Job Summary

As the new Senior Regulatory Affairs Manager, you will provide regulatory expertise, leading all aspects of regulatory for drug-device combination product development from early stage clinical through to commercialisation.

As part of the remit you will also:

  • Develop and review of regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies;
  • Maintain full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, PRIME and Market Authorisation Applications (MAAs)
  • Maintain timelines for full regulatory submissions;
  • Provide regulatory advice and guidance to Sponsors and cross-departmentally to ensure compliance with UK and European regulations and requirements;
  • Developing scientific and regulatory documents for EU agency meetings;
  • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
  • Manage and Mentor junior staff members

The Person

The ideal candidate will have a degree in a science related field. You will also have a minimum of 5 years' experience within the field of Regulatory Affairs, working with a pharmaceutical company or CRO.

As the new Senior Regulatory Affairs Manager, you will also possess the following characteristics:

  • Ability to work strategically within a complex, business critical and high-profile program.
  • Significant regulatory affairs experience within MHRA and EU regulations and procedures.
  • Strong computer skills, project management skills, and a high attention to detail

Compensation

Market leading salary and benefits package.

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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