Junior Regulatory Affairs Associate Job at Parexel (Petaling Jaya)

Job Description

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Job Responsibility

Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, 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
Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
Develop a familiarity with current global regulatory submission standards
Develop a familiarity with departmental standard operating procedures and work instructions
(Regulatory Affairs only) Under supervision provide support to currently marketed products

Requirements

Bachelor’s Degree in a Scientific or Technical Discipline
0-2 years’ experience in an industry-related environment
Works effectively within a team environment
Works within broad project guidelines as directed by the project Technical Lead or Project Manager
With the guidance of the project Technical Lead or Project Manager, demonstrates the ability to prioritize work to achieve specified project outcomes
Capitalizes on opportunities to improve performance and seeks feedback from the project Team Lead and colleagues
Applies information provided by the project Team Lead or senior colleagues to complete assigned project activities
Produces quality work that meets the expectations of Project Lead and the client
Completes assigned activities within project scope and objectives under the direction of the Project Lead
Identifies project and internal issues to senior colleagues and Project Lead
Interacts professionally at all working levels within a client organization and within Parexel
Identifies project and/or client needs to the Project Lead
Meets established metrics as specified in scorecard on an annual basis
Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
Defines self-development activities with the support of management to keep current within the industry

Nice to have

Communicator
Detail-oriented
Problem-solver
Relationship-builder
Results-driven
Strategic

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
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Junior Regulatory Affairs Associate

Job Description

Job Responsibility

Requirements

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