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Regulatory Submissions Associate

Employer
Labcorp
Location
Maidenhead, Berkshire (GB)
Salary
Competitive salary and benefits
Start date
11 Mar 2019
Closing date
10 Apr 2019

View more

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

Job Details

Job Summary

Covance is expanding and is looking to recruit a Regulatory Submissions Associate II to join the team at our Maidenhead office. The role is responsible for providing support to regulatory managers and others for the timely submission of information to Regulatory Authorities in support of investigational and marketed products. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Covance groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements. It is the responsibility of the Regulatory Associate to prepare documents to the required standard and to maintain awareness of current regulatory standards related to submissions for drug and biologic products.

Essential Job Duties:

  • Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs). May take ownership of specific pieces of work.
  • Contribute to the preparation of submissions to Health Authorities by reviewing/summarizing scientific/research documents.
  • Assist in the coordination, collection and organization of information required by Regulatory Authorities.
  • Assist in client meetings and proactively liaise with clients on Regulatory Submission issues.
  • Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
  • Maintain knowledge and awareness of regulations and guidelines pertaining to drugs and biologics.
  • Monitor compliance with regulatory requirements in relation to assigned projects.

Job Qualifications:

  • Bachelor’s Degree in Life Sciences or equivalent.
  • Experienced with RA submissions and should have knowledge on the laws and regulations concerning clinical research.
  • Excellent communication skills, organization and planning skills and attention to detail.
  • Must be able to communicate effectively in the English language.

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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