Regulatory Affairs - Publishing

4 days ago

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Parexel

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• A Regulatory Affairs Associate must have knowledge of the organization’s basic consulting models and methodologies. • A Project Leader must be technically competent and continually developing skills defined in the department. • Assists in the production of submissions and delivery of regulatory services according to agency guidelines. • Works effectively within a team environment, reporting to Line Manager and Supervisor. • Responsible for ensuring client work is performed and delivered on time, meeting quality expectations. • Provides electronic publishing services, including preparation of submission packages and document management tasks. • Capitalizes on opportunities to improve performance and seeks feedback from Manager and colleagues. • Produces quality work that meets the expectations of the department and client needs.

Requirements

• Minimum 2 - 5 years of experience in an industry-related environment. • Preference for regulatory knowledge and ICH Guidance. • Scientific (Pharmaceutical, Biochemistry, Biotechnology, others) or Technical Discipline (Translator, IT). • Very good verbal and written English.

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