Senior Regulatory Affairs Associate - Fsp

**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. **This FSP Team - Senior RA Associate opening may need to go into Client's office 2-3 times a week.** **Location: Melbourne** **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