Junior Regulatory Affairs Associate

The Junior Associate assists in the assembling of submissions (low complexity post-approval changes in CTD or non-CTD format such as leaflet and packaging notification, administrative changes, renewals, support with Annual Reports activities, support with CMC changes and GMP Renewals for vaccines, biological products and small molecules) and delivery of regulatory services (support on system´s updates and system´s activities to maintain the records of product´s updated) by ANVISA guidelines while balancing the quality and timeliness of customer deliverables. 
A Junior Associate must be technically competent, stay up to date with the most recent ANVISA´s guidelines, and develop the skills defined in this document's responsibilities section. A Junior Associate, under the general direction of a Project Lead, takes responsibility for ensuring that client work is performed and delivered on time, meeting the quality expectations of Regulatory Outsourcing Services and the client. More senior staff may need guidance to accomplish more complex tasks.

Key Accountabilities:

Project Administration:

• Under supervision, provide electronic publishing services including document preparation, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.
• Provide basic regulatory affairs service,s including preparing submission packages Capitalizes on opportunities to improve project efficiency, results or team performance and proactively proposes news ways of working within the team.

Document Management:

• Under supervision, perform basic document management tasks including file transfer, storage, tracking, and archival of dossiers submitted to ANVISA
• 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:

• (Regulatory Affairs only) Under supervision, provide support to currently marketed products.

Skills:
Project Execution:

• 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.
• Seeks efficiency in the delivery of assignments.
• Applies information provided by the project Team Lead or senior colleagues to complete assigned project activities.
• Produces quality work that meets the expectations of the Project Lead and the client.

Relationship Management:

• 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
• Identifies new ways of supporting the client and team.
• Leverage from the interactions with more senior staff to improve knowledge on the local Regulatory landscape

Parexel-Related Responsibilities:

• 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

Knowledge and Experience:

• 1-2 years’ experience in an industry-related environment in Regulatory Affairs

Education:

• Bachelor’s Degree in a Scientific or Technical Discipline.

This is a home-based position, but you must go to the office in São Paulo once a month.