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Senior Regulatory Affairs Associate

Thailand, Remote Date posted 08/06/2022 Job ID 84128BR

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

A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. A Senior Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. A Senior Associate may act in a client facing role with support from line management. 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 PC’s quality expectations.

Job Description:

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 PC management and account managers
  • May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Job Qualifications:

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 with support from line management. 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 of clinical trial

Education:

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline. BPharm degree is a plus.

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