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Regulatory Affairs Consultant

Taipei, Taiwan, Taiwan Date posted 04/22/2025 Job ID R0000031485

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

*Works effectively within a team environment but may work independently delivering services within their area of competence (may include NDA, DMF, PMF, BSE, post-marketing variations, CTA and amendments, etc.). 

*Lead on regulatory projects as a Regulatory Lead or Project Lead. Responsible for project planning, set-up, finance control. 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.
*Provides technical and/or business consulting services within personal area of expertise.
*Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project team.
*Produces quality work that meets the expectations of project team and the client.
*Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability.
*Proactively assesses client needs and develops processes and solutions to address issues.
*May participate in project scoping calls and/or proposal preparation with the support of senior colleagues.

*Participation in internal initiatives/projects or as a mentor as requested by management.

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