Company Name: Pharmaceutical Research Associates, Inc.
Position Title: Associate Regulatory Submission Manager
Hours: Monday – Friday, 8:00 am to 6:00 pm
Location: 31 St. James Avenue, Suite 1020, Boston, Massachusetts, 02116
Coordinate timely compliant submissions prepared for global regulatory agencies in accordance with the global regulatory plan. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. Implement submission strategy plans, including timelines and resource projections according to submission type. Maintain submission projections in alignment with department standards. Plan detailed submission timelines. Raise timeline concerns, risks, and issues that may delay or impact the project. Engage appropriate representatives to manage outcomes. Ensure project teams understand document submission principles, lifecycle management, and regional differences impacting submission preparation. Provide recommendations for formatting standards and contents of submission documents. Contribute to the creation of templates and associated training materials. Report and provide status updates to key stakeholders of projects. Communicate with regulatory authorities on technical matters.
Bachelor's degree in Regulatory Affairs, Project Management, or related field and five (5) years’ experience in Regulatory Publishing Manager, Regulatory Affairs Manager, Regulatory Operations Lead, Regulatory Project Manager, or related role. Five years' experience in: MS Project, Gantt chart manipulation, resource planning, process mapping, and creating work breakdown structures. Two years' experience in: global project teams and how the functional departments are interconnected in order to introduce efficiencies; global filing experience in countries such as Europe, Asia, South America, North America, Russia, and Africa; and pre-submission activities for global markets when developing long term submission forecasts such as briefing books and pediatric investigational plans.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.