Associate Manager, Regulatory Submissions

Help deliver regulatory submissions for a Fortune 500 Company, where you will coordinate cross-functional teams, maintain project plans, and contribute to process improvement and technology initiatives.

Have 4+ years of experience in project management, regulatory affairs, science, operations, or a related field? If so, we want to speak with you! We are currently seeking an Associate Manager, Regulatory Submissions, to join our Regulatory Affairs organization in Richmond, VA, with a hybrid work schedule.

Relocation benefits will be provided.

The Associate Manager supports end-to-end project execution by coordinating resources, maintaining timelines, tracking progress, and helping identify risks and resolve issues across cross-functional teams.

You will also help build and maintain the tools, procedures, dashboards, and performance metrics that keep our submission work organized, compliant, and on time.
What you will be doing:


* Coordinate cross-functional teams to deliver regulatory submissions by maintaining project plans, tracking timelines, facilitating meetings, and escalating risks and issues


* Organize and compile information and data for regulatory submissions, compliance activities, and FDA inquiries in line with state and federal requirements


* Maintain and improve submission-management tools, including trackers, checklists, dashboards, and risk logs, and turn project data into clear status updates and metrics


* Help implement our Regulatory Information Management (RIM) system, working with business system, technology, and external partners


* Develop and maintain SOP/QMS documentation, work instructions, templates, and training materials that standardize processes, simplify workflows, and drive continuous improvement


* Manage submission review and quality control activities to help ensure submissions are accurate, consistent, complete, and aligned with applicable regulatory requirements

We want you to have:


* Bachelor's degree preferred in science, engineering, operations, business, project management, information systems, or related discipline


* 4+ years of relevant experience preferred in project management, regulatory affairs, science, operations, quality systems, IT-related fields, or cross-functional execution support


* Experience using or implementing Regulatory Information Management (RIM) systems


* Understanding of project management processes, preferably supporting FDA regulatory submissions, including familiarity with PMTA, MRTPA, SE/SE Ex, and tobacco compliance submissions


* Experience supporting or maintaining project plans, governance routines, dashboards, risk-management tools, quality/process documentation, training materials, and resource models.


* Ability to synthesize large amounts of data and support accuracy in regulatory reporting


* Communication and stakeholder management skills, and a proven ability to meet timelines


* Proficiency in Microso...