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Senior Regulatory Affairs Associate - FSP at Parexel, Australia North Ryde Remote

Senior Regulatory Affairs Associate - FSP at Parexel in Australia North Ryde Remote. Full-time. Est. up to $80k. Apply with swipeandhired.

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 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 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 4-5 + 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