This Senior Regulatory Affairs Associate is for FSP team to provide post-authorization lifecycle management, prepare/ organize/ coordinate local specific documentation to maintain regulatory compliance and support HA inspections, as needed.

Strong knowledge and hands-on experience in Australia and New Zealand is required.

Key Accountabilities:

Project Execution

- Previous experience working in industry in support of Global and/or local Regulatory teams, with comprehensive understanding of regional and global regulatory requirements, guidelines and processes and in-depth expertise on local health authority management
- Strong knowledge of post-authorization lifecycle maintenance procedures e.g. variations, renewals, PSURs, etc, timelines and requirements, to support maintenance of multiple licenses, including management of HA interactions and responses to questions
- Use of document management tools (internal systems) and external platforms
- Prepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation ( renewals, PSURs, label updates, CMC changes)
- Ability to manage/coordinate impact assessments for technical changes impacting marketing authorization, including working with various non-regulatory stakeholders, such as medical, marketing, manufacturing sites etc.
- Stay updated on local regulatory requirements, and guidelines,



to ensure compliance with regulations and effectively communicate requirements to GRA and other team members as needed; participate actively in regulatory meetings, share insights and best practices within the organization
- Maintain regulatory compliance and support HA inspections, as needed
- Works effectively within a team environment but may work independently delivering services within their area of competence
- Works within broad project guidelines as directed by the project lead and/or technical SMEs
- Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager
- Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues
- Applies information provided by the project lead or senior colleagues to complete assigned project activities
- Produces quality work that meets the expectations of project lead and the client
- May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects, and would be responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)




- Functions as the main client contact and ensures accurate project reporting is in place
- Ensures that the project team delivers to meet the client expectations for quality and timeliness
- Ensures that appropriate risk identification and issue-escalation procedures are in place
- Ensures project specific training compliance of the project team
- Ensures and/or manages project financials including provision of accurate revenue forecasts
- Ensures that the project team understand and work to the scope of the contract
- Identifies current opportunities through Change In Scope or add-on business from existing work
- Ensures timely project close-out activities are completed

Consulting Activities and Relationship Management

- Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME
- Delivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SME
- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and/or Technical SME
- Identifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutions
- Interacts professionally at all working levels within a client organization and within Parexel
- Identifies project and/or client needs to the Project Lead and or Technical SME and collaborates with senior staff to define a proposed solu

📌 Senior Regulatory Affairs Associate (Australia)
🏢 Parexel
📍 Australia