Senior Regulatory Affairs Associate (RA Generalist) - FSP

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 new 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 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 Business Development Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience Communicates potential new business leads to PC management and account managers May participate in project scoping calls and/or proposal preparation with the support of senior colleagues Parexel-Related Activities Meets established metrics as specified in scorecard on an annual basis Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by management Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association) Skills: Project management knowledge Client-focused approach to work Results orientation Teamwork and collaboration skills Excellent interpersonal and intercultural communication skills, both written and verbal Critical thinking and problem-solving skills Proficiency in local language and extensive working knowledge of the English language Knowledge and Experience: More than 3-5 + years of experience in an industry-related environment in Australia including New Zealand Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline