SRG is a global staffing and consulting firm and we are looking for a Regulatory Specialist for a 6 month project in Richmond, VA!
POSITION SUMMARY: Under the supervision of the Regulatory Affairs Manager, this position is responsible for providing support with activities related to our marketed product portfolio through the products lifecycle and maintaining compliance with US Food and Drug Administration (FDA) regulations. The role of the Regulatory Affairs Associate is to provide support for Existing Product Development (EPD) during lifecycle management. The candidate will work cross-functionally and provide support to teams such as Regulatory Strategy/CMC, Regulatory Operations, Promotional Review Committee (PRC), and Risk Evaluation and Mitigation Strategy (REMS). The candidate must be a team player who listens objectively, exercises good judgment, asks incisive questions and is able to perform and track multiple tasks on several projects.
The responsibilities of this job include, but are not limited to, the following:
· Prepare and manage regulatory submissions (e.g., supplements, amendments, correspondence to FDA, etc.) as well as support key stakeholders in the preparation, and QC for investigational and/or marketed drug products.
· Develop relationships with key stake holders (e.g., Regulatory Operations) to establish and maintain submission planners and associated timelines and facilitates tactical submission team meetings.
· Provide support to Regulatory REMS as assigned (e.g., research regulations, guidance, submission support, etc.).
· Coordinate and support the team in planning and preparation for FDA meetings and/or teleconferences.
· Maintain and update internal records in appropriate document management systems.
· Manage the 2253 submission process.
· Work with internal teams to establish appropriate procedures for submission(s) per SOPs.
· Assist with drafting cover letters, FDA forms and response documents as necessary.
· Create regulatory objectives in the appropriate document management system.
· Maintain a submission calendar and work closely with internal teams to schedule, upload appropriate documents and route documents for review and approval to meet submission deadlines.
· Provide support with Annual Reports by holding kick-off meetings, coordinate section updates/review.
· Lifecycle submissions, upload health authority correspondences and keep the regulatory system up to date with all submission activity.
· Upload health authority correspondences utilizing the appropriate document management system.
· Create regulatory objectives and lifecycle objectives throughout the submission, review and approval process.
· Draft and communicate meeting agendas and facilitate prioritization.
· Determine the time and effort required to complete each submission, and work with the appropriate teams to integrate into the project timelines to ensure sufficient time for review and approval and on-time delivery for submission.
· Participate in monitoring/auditing of the PRC process, as appropriate.
Education: Bachelor degree in science related field, business, healthcare or other related discipline
· 1-3 years of Pharmaceutical experience preferably in a regulatory environment
· Some knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
· Excellent communication skills, both verbal and written
your application has been submitted