Regulatory Affairs Associate

Job Description Summary

The Associate performs the assembling of submissions (post-approval changes in CTD or non-CTD format such as leaflet and packaging notification, administrative changes, renewals, Annual Reports, CMC and clinical related variations and GMP Renewals for vaccines, biological products and small molecules) and delivery of regulatory services (support on system´s updates and system´s activities in order to maintain the records of product´s updated) in accordance with ANVISA guidelines while balancing the quality and timeliness of customer deliverables.

An Associate must be technically competent, staying up to date with the most recent ANVISA´s guidelines, developing the skills as defined in the responsibilities section of this document. An 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. The guidance of more senior staff may be needed to accomplish more complex tasks.

Key Accountabilities:

Project Administration:

• Provide electronic publishing services including document preparation, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.
• Provide regulatory affairs services 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:

• 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 for efficiency on 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 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 interactions with more senior staff to improve knowledge on the local Regulatory landscape

Qualifications:

• Understanding of regulatory processes for medicinal products. Experience with different product categories (small molecules and biologics) is a plus
• Good Organizational skills
• Knowledge of Microsoft Office
• Attention to detail and good oral and written communication skills; and
• Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:

• 3-4 years’ experience in an industry-related environment in Regulatory Affairs

Education:

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