Regulatory CTA Consultant

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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