Regulatory Affairs Assistant

Project Administration

• Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering,

bookmarking, compilation, table of contents creation, pagination, and formatting of reports and simple submissions.

• Provide basic regulatory affairs services including preparing submission packages Capitalizes on opportunities to improve project efficiency, results

or team performance and proactively takes action

Document Management

• Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival.

Regulatory Guidelines

• Develop a familiarity with current global regulatory submission standards.

Standard Operating Procedures

• Develop a familiarity with departmental standard operating procedures and work instructions.

Product Support

• Under supervision provide support to regulatory activities related to marketed/investigational products.Qualifications[Skills]

• Project management knowledge

• Client-focused approach to work

• Results orientation

• Teamwork and collaboration skills

• Communication skills

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Critical thinking and problem-solving skills

• Proficiency in local language and extensive working knowledge of the English language

[Knowledge and Experience]

• Initial years of experience in an industry-related environment

[Education]

Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline(pharmacy background is preferred)