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