Regulatory CTA Consultant
An attractive job opportunity has arisen at a leading multinational pharmaceutical company who is looking for a Regulatory CTA Consultant.
- 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.