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Senior Regulatory Affairs Associate

May 2, 2026

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.Key Accountabilities:Act as primary RA representative for local Commercial and medical team: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy.Assess and mitigate impact of changes with local teamProject Execution<ul><li>Responsible for product and GMP registration dossier preparation and submission of assigned projects.</li><li>Responsible for timely ordering of registration sample, dossier, certificates etc.</li><li>Contribute to the discussion of registration plan with both local and global team.</li><li>Track the registration status in TFDA and timely report to the line manager.</li><li>Address technical questions from TFDA.</li><li>Communicate with global/ regional teams on issues related to product registration, TFDA lab product testing</li><li>Review of promotional materials and labeling.</li><li>Monitor regulation changes and report in timely manner.</li><li>Ensure regulatory activities comply with internal Code of Conduct and SOPs</li><li>Regulatory support to cross functions and department</li><li>Responsible for product and GMP registration dossier preparation and submission of assigned projects.</li><li>Responsible for timely ordering of registration sample, dossier, certificates etc.</li><li>Contribute to the discussion of registration plan with both local and global team.</li><li>Track the registration status in TFDA and timely report to the line manager.</li><li>Address technical questions from TFDA.</li><li>Communicate with global/ regional teams on issues related to product registration, TFDA lab product testing</li><li>Review of promotional materials and labeling.</li><li>Monitor regulation changes and report in timely manner.</li><li>Ensure regulatory activities comply with internal Code of Conduct and SOPs</li><li>Regulatory support to cross functions and department</li><li>Works effectively within a team environment but may work independently delivering services within their area of competence</li><li>Works within broad project guidelines as directed by the project lead and/or technical SMEs</li><li>Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager</li><li>Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues</li><li>Applies information provided by the project lead or senior colleagues to complete assigned project activities</li><li>Produces quality work that meets the expectations of project lead and the client</li><li>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.)</li><li>Functions as the main client contact and ensures accurate project reporting is in place</li><li>Ensures that the project team delivers to meet the client expectations for quality and timeliness</li><li>Ensures that appropriate risk identification and issue-escalation procedures are in place</li><li>Ensures project specific training compliance of the project team</li><li>Ensures and/or manages project financials including provision of accurate revenue forecasts</li><li>Ensures that the project team understand and work to the scope of the contract</li><li>Identifies new opportunities through Change In Scope or add-on business from existing work</li><li>Ensures timely project close-out activities are completed</li></ul>Consulting Activities and Relationship Management<ul><li>Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME</li><li>Delivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SME</li><li>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</li><li>Identifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutions</li><li>Interacts professionally at all working levels within a client organization and within Parexel</li><li>Identifies project and/or client needs to the Project Lead and or Technical SME and collaborates with senior staff to define a proposed solution</li><li>Interactions result in clients expressing satisfaction with service provided</li><li>May assist in preparing and/ or delivering a presentation with the support of senior colleagues</li><li>Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope</li></ul>Business Development<ul><li>Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience</li><li>Communicates potential new business leads to PC management and account managers</li><li>May participate in project scoping calls and/or proposal preparation with the support of senior colleagues</li></ul>Parexel-Related Activities<ul><li>Meets established metrics as specified in scorecard on an annual basis</li><li>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</li><li>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)</li></ul>Skills:<ul><li>Project management knowledge</li><li>Client-focused approach to work</li><li>Results orientation</li><li>Teamwork and collaboration skills</li><li>Excellent interpersonal and intercultural communication skills, both written and verbal</li><li>Critical thinking and problem-solving skills</li><li>Proficiency in local language and extensive working knowledge of the English language</li></ul>Knowledge and Experience:<ul><li>Few years of experience in an industry-related environment</li></ul>Education:<ul><li>Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline</li></ul>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...