Global Regulatory Affairs Manager – US/Canada – Home Based
- Job Locations(All) | US-Remote
- ID: 2019-54193
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Who are we?
We Are PRA.
We are 16,000+ 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 are getting live saving drugs into the hands 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 Manager is responsible for the preparation and coordination of global regulatory submissions or to provide regulatory or logistics support, as appropriate in accordance with the assigned role, for clinical trials.
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) and other applicable PRA systems.
- Perform role of global reviewer in the QC process as appropriate
- Applies expert understanding and application of PRA processes, SOPs and work instructions
- Applies knowledge of computerized information systems and standard application software
- (Windows, MS Office).
- Demonstrates expert understanding and application of clinical research regulations, concepts, practices and standards.
- Proven history of successful interaction with PRA project teams and a basic understanding
- of each related function.
- Demonstrates an excellent understanding of country requirements and how they need
- clinical trial environment.
- Successfully represents PRA both internally and externally.
- Exhibits good decision making skills utilizing all available resources for determining positive outcomes
What you need to have:
- Bachelor’s degree or its international equivalent from an accredited institution or a licensed healthcare professional (i.e. registered nurse) or logistics specific background, as appropriate or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
- Proven history of functional or regulatory management is 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.
- Minimum 5 years of prior experience preparing RA and Central IEC submissions for Clinical Trial Applications or logistics support for relevant type of activities, as appropriate, preferred.
- 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 Education and Experience:
- Degree in clinical, science, or health-related field.
- CRO experience.
- 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.