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REGULATORY ASSOCIATE

Employer
Pivotal
Location
United Kingdom
Salary
Competitive
Start date
8 Feb 2021
Closing date
10 Mar 2021

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

Job Details

DESCRIPTION:

We have an opening position for a REGULATORY ASSOCIATE with at least 2-3 years of experience to join our Regulatory unit within the clinical operation department.

The Regulatory Associate is responsible for routine regulatory support and for providing guidance to support timely filings and maintenance of assigned programs.  Compile and maintain regulatory documentation databases or systems and coordinate efforts associated with the preparation of regulatory documents or submissions.

 

REQUIRED PROFILE: We are looking for candidates with the following skills

  • Science Degree with at least 2-3 years of experience in Regulatory/start-up on clinical trials. Sound knowledge of GCPs/ICH and international/local regulations Updated knowledge of national/international regulations relative to clinical Trial Start Up Procedures.
  • Previous experience in/with
    • Preparation of the request for clinical trials authorization
    • Competent Authority (CA) and REC/HRA and R&D submissions;
    • Contract and budget negotiation with sites as needed
  • Fluent in English Team Management Good knowledge of Office (Word, Excel and Powerpoint)
  • Above all, we appreciate motivation, excellent team player, and independent and well-structured way of working

Company

Pivotal was born in 2001 surrounded by an environment of high scientific tenure and drive. Our founder, Dr. Ibrahim Farr, launched Pivotal to share and implement scientific strategies and best project practices that make clinical trials more efficient and maximize our client’s drug development programmes.

We are a company with as many as 200 employees and operating in 20 countries we have built focused specialization across all therapeutic areas and founded a strong oncology, innovative therapies and early phases hub that enable us to tackle our customers’ most difficult challenges. After 20 years of hands-on experience, we master clinical research.

Pivotal has heavily invested in becoming a data- driven CRO that prioritizes mobility. We dive deep into clinical trials by leveraging our near real-time advance analytics and visualization platform. We discover data-driven insights to anticipate trial risks and predict their impact. We are a technology-savvy organization. This has made us an efficient, agile and resilient company that is very focused on our customers.

Our approach to clinical research can be summarized in our Innovative Organization Model: connected with the clinical research and technology ecosystem, data-driven, agile and customer-centric.

Company info
Website
Location
Calle Gobelas 19, La Florida
28023 Madrid
ES

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