Senior Regulatory Affairs Associate

1 day left

Location
England, London
Salary
£45000 - £51000 per annum + competitive benefits
Posted
11 Jan 2021
Closes
25 Jan 2021
Ref
#21147
Contact
Dominic Bellenger
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Entry level

Senior Regulatory Affairs Associate

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

Job Summary

As the new Senior Regulatory Affairs Associate, 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 2 years' experience within the field of Regulatory Affairs, working with a pharmaceutical company or CRO.

As the new Senior Regulatory Affairs Associate, 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.

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