Senior Regulatory Affairs Associate
Seoul, Korea, Republic of Job ID R0000029040 Category Regulatory / Consulting Date Posted 11/04/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
*IND, NDA, 임상시험승인계획신청, 품목허가(변경)신청및관리등, 최소 3년이상의 RA 업무경험자 (국내허가관련업무의경력자) 우대
*Chemistry, Biology, Pharmacy 혹은그외유관전공학사이상
*Parexel 오피스/ 재택근무병행
Key Accountabilities:
Project Execution:
- 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 when serving as a Project Lead
- 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:
- Few years of experience in an industry-related environment
Education:
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
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