Regulatory CTA Consultant job in Uxbridge, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Consultant / Specialist

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

An attractive job opportunity has arisen at a leading multinational pharmaceutical company who is looking for a Regulatory CTA Consultant.

Job Responsibilities

Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess.
Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
Responsible for the co-ordination of translations for core documents required for submission
Manages the compilation for core package build, contributing to CTA and authoring documentation as required
Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory (CTR).
Promotes professional development through mentoring and motivating colleagues.
Drives connectivity and implements refinements in the Emerging Markets partner model through collaboration with peers
Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently

Skills and Requirements

B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology
In-depth understanding and proven execution of CTA processes globally
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
Understanding of EU Clinical Trial Regulation Desirable

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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