Senior Regulatory Affairs Associate

Posted 3 Days Ago
Be an Early Applicant
Taipei City, TWN
In-Office
Senior level
Pharmaceutical
The Role
Provides regulatory consulting and project execution support for clinical development engagements. Responsibilities include managing project activities, client relationships, timelines, risks, training compliance, financial forecasting, reporting, scope changes, and closeout. The role also contributes to consulting deliverables, presentations, business development, proposals, and internal compliance activities while maintaining scientific and regulatory industry knowledge.
Summary Generated by Built In

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:

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, 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:

  • Few years of experience in an industry-related environment

Education:

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

Skills Required

  • A minimum of a Bachelor's Degree in a Scientific or Technical Discipline
  • A few years of experience in an industry-related environment
  • Proficiency in the local language
  • Extensive working knowledge of the English language
  • Project management knowledge
  • Excellent written and verbal communication skills
  • Critical thinking and problem-solving skills

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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