Parexel

Senior Associate, Regulatory Affairs CTA Lead

Company
Parexel
Location
Wavre, Belgium
Salary
Competitive
Posted
17 Jun 2021
Closes
17 Jul 2021
Ref
70927BR
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Description

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Due to a growing portfolio, we are currently looking for experienced Senior Associate, Regulatory Affairs CTA Leads who will be outsourced to one of our pharmaceutical client partnerships. You will need to be EU based, and we are flexible with homebased or office-based candidates. You will beaccountable for leading operational submissions execution for designated CTAs. You will operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.

Role Responsibilities:
  • Drives global submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
  • Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
  • Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
  • Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes
  • Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
  • Responsible for the co-ordination of translations for core documents required for submission
  • Manages the compilation for core package build, contributing to CTA and authoring documentation as required
  • Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
  • Discuss with relevant SMEs the interpretation of dossier requirements
  • Qualifications

    Skills & Experience
  • BS/BSc in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
  • In-depth understanding and proven execution of CTA and Central Ethics processes globally
  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
  • Fluency in English is a must (any additional European languages are a plus)
  • Substantial Experience in Regulatory Affairs and Clinical Research

  • You will be rewarded with a competitive salary and benefits package! And we can offer extensive career development within our growing Regulatory portfolio.Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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