Global Regulatory Affairs Associate

Company: PRA Health Sciences
Location: Remote
Posted on: May 3, 2021

Job Description:

Overview

We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.

Who are we?

We Are PRA.

We are 20,000+ employees strong, operating in more than 90+ 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 leader that isn't afraid to delegate, but also isn't afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for labeling. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. 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.

The Global Regulatory Affairs Associate (GRAA) fulfills the role of Global Regulatory Affairs Lead (GRAL) and is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met (except in the United States and Canada, where the GRAL does not coordinate central IRB/IEC submissions).

Responsibilities

What you will be doing:

• 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 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), eTMF and other applicable PRA systems.Perform role of Global Reviewer in the QC process as appropriate.
• Act as GRA partner to support the Country Consultant and complete review of Country Fact Sheets to timelinesfor assigned country(s).
• Take on responsibility for Subject Matter Expert as designated by GRA Management.
• 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
• Provide mentoring and training for the GRAA 1 and GRAA 2 position.
• Support GRAA 1 and 2 with more complex submissions requirements.
• 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.
• Support the development of new processes.
• May provide line management to direct reports, including professional development, performance appraisals and employee counseling/mentoring.
• May manage and coordinate resources and reviews workloads of direct reports.

Qualifications

What you need to have:

• 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) required or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
• Expert knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
• Minimum 2 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.

Preferred Experience:

CRO experience preferred.With Director approval and in special circumstances, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

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

Keywords: PRA Health Sciences, Eugene , Global Regulatory Affairs Associate, Other , Remote, Oregon