Senior/ Regulatory Affairs Associate
Thailand Job ID R0000031452 Category Consulting Date Posted 02/27/2025Overview
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
Qualification
- Knowledge and Experience:
- A Senior Associate must have an understanding and experience of consulting models and methodologies
- A Senior Associate must have good knowledge of regulatory requirements of IND/CTA/NDA and have experience of filing clinical trial application or import license application successfully to health authorities.
- A Senior Associate shall have experience of taking a Technical SME for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the client.
- A Senior Associate may act in a client facing role. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and Parexel's quality expectations.
- More than 3 years of experience in regulatory affairs or SSU for clinical trials
- Education:
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline. BPharm degree is a plus.
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
- May serve as a Project Lead or a Work Stream Lead. PL shall be responsible for project planning and set-up, till all project close-out activities are completed, which could include project delivery of scoped work, project financials, forecasts, training compliance, risk identification/issue escalation with solutions, etc.
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
Business Development
- Communicates potential new business leads to consulting management and account managers
- May participate in project scoping calls and/or proposal preparation with the support of senior colleagues
Employee Insights
Why Consultants work at Parexel
