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 new opportunities through Change In Scope or add-on business from existing work
Ensures timely project close-out activities are completed
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 solution
Interactions result in clients expressing satisfaction with service provided
May assist in preparing and/ or delivering a presentation with the support of senior colleagues
Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope
