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Manager of Global Reg Affairs
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Who are we?

We Are PRA.


We are 16,000+ employees strong, operating in more than 80 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.


Who are you?


You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Sr Compensation Analyst, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.


Still here? Good. Because if this is you, we’d really like to meet you.


What will you be doing?

Provides technical knowledge and support of clinical trials applications, regulatory requirements for study start up and clinical trials application maintenance for both internal customers and external clients related to investigational drugs biologicals and medical devices. Primary job responsibilities include the preparation and coordination of global regulatory submissions to support the initiation of clinical trials for investigational drugs. Supports business development efforts. May participates in project teams, leads specific regulatory tasks, and serves as regulatory lead on multiple projects. Manages internal resources and projects to completion. May also work to support clients on European Union/United States stand alone regulatory projects.


When assigned to perform the GRAL role:

  • Coordination of Central Independent Ethics Committee (Central IEC), Regulatory Agency (RA) and other central or country level authority submissions to ensure contractual timelines are met.
  • Provide the client and the internal team information on regulations and drug considerations at a project level and answer client questions surrounding these.
  • Provide submission strategy to the client along with all requirements and documentation requests to actualize proposed strategy.
  • Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements.
  • Depending on the scope of the project, create the master IP labels or ensure that Sponsor provided IP labels are in adherence with Annex 13 or applicable regional requirements.  Coordination of country level labeling translation.
  • Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS) and other applicable PRA systems.  
  • Perform role of Global Reviewer in the QC process as appropriate.

When assigned to perform the LRAL role:

  • Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee(IEC) and any other central authorities for the assigned country/countries.
  • Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
  • Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
  • Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate.
  • Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems. 
  • Perform role of Local Reviewer in the QC process as appropriate.
  • Providing consultancy to the client on any country specifics issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM).
  • Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM.
  • If applicable for the Country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation and the project-specific contractual agreement.

When assigned to perform the RAAL role:

  • Management of activities associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) including:
     - liaison with applicable parties (i.e. drug depots, customs agents, courier companies etc) to ensure IP and clinical trial supplies are available in country to meet the needs of the trial and that import/export requirements are met;
     - tasks required to set up a local depot as required, including budget agreement, liaison with PRA legal regarding contract negotiation etc;
     - management and tracking of shipments;
     - organisation of local purchase of study related materials including drugs, supplemental materials, equipment etc;
     - preparation or review of required documentation including export documents, import/export license submission packages pro forma invoice templates etc;
     - organisation of relabeling and destruction processes at Depot and ensuring that all study materials are returned to Sponsor at study end.   
     - management of vendor invoices (verification, negotiation with Project Manager (PM), Project Analyst (PZ) and PRA accounts department)
  • Determine country level/central importation/exportation requirements for the country(s); advise project team of the requirements of logistics procedures in the country(s) and ensure that documentation and procedures meet the requirements of the country(s) and the project.  
  • Ensure that IP labels are in adherence to country requirements and to study related documents (e.g. Certificate of Analysis, Letter of Authorisation, protocol etc.).
  • Tracking and reporting of all logistics related activities in PRA systems.  
  • Attend internal and external project team meetings as determined by the GRAL/Start-Up Lead (SUL)/Clinical Trial Manager (CTM) or Project Manager (PM)
  • Appropriate escalation of issues. 
  • Act as local reviewer to QC documentation prepared for submission.

When assigned as Functional Manager:

  • Provide line management to direct reports, including professional development, performance appraisals and employee counseling/mentoring.
  • Management and coordination of resources and reviews workloads of direct reports. 


  • Act as GRA partner to support the Country Consultant and complete review of Country Fact Sheets to timelines for assigned country(s).
  • Take on responsibility for Subject Matter Expert as designated by GRA Management.  
  • May perform the role of Local Reviewer in the QC process as appropriate.
  • May perform quality control of core document packages for RA and Central IEC submissions.  
  • Provide mentoring and training for less experienced team members. 
  • Support more junior team members with more complex submissions requirements.
  • Support the development of new processes.
  • May be delegated ownership for areas of the Country Knowledge Repository and be responsible for liaising with other operational departments to ensure the database contains accurate Country intelligence.
  • Lead and support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs, including representing GRA at internal and external BD meetings.
  • Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team.  
  • May work with GRA team members to provide Regulatory consulting services


  • Proven history of functional or regulatory management required.
  • Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
  • Prior experience with regulatory submissions such as MAAs, NDAs, INDs and global CTAs required 
  • Minimum 5+ years prior experience preparing RA and Central IEC submissions for Clinical Trial Applications preferred.
  • Expert knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
  • Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required.
  • Read, write, and speak fluent English; fluent in host country language.
  • Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) preferred.
  • CRO experience preferred.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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