Regulatory Manager - Extended Producer Responsibility Programs - Inmar, Inc.
Winston Salem, NC 27101
About the Job
This role indirectly manages internal and external resources to ensure successful completion of regulatory technical projects, keeping leadership informed of key issues that may impact project completion, compliance, budget or other results.
Major Responsibilities/Essential Functions:
Program Management (30%)
Apply general knowledge of project management principles, tools, and processes to lead assigned project(s)
Assist with the execution of stewardship plan,budgets and annual report submissions as guided by regulations, drafting outlines and working with internal teams as necessary to compile all the necessary information to submit plan/reports
Coordinate with cross-functional teams within the organization to ensure all functional areas have been addressed
Complete the plan schedule and work breakdown structure to estimate effort and duration of project tasks; confirm assignment of resources and validate completion date targets for project tasks
Effectively manage project scope by ensuring any changes are documented, vetted, and approved via a clearly defined change management process
Track and report project status and key metrics to project stakeholders regularly
Assess risks and identify gaps with established plans
Ensure problems, issues, and risks that may affect project goals are identified, documented, and resolved
Ensure processes are in place for effective communication, testing, training and documentation, go-live and transition activities to occur throughout the project lifecycle
Complete post-project evaluation to determine how well results were achieved and provide insight for improvement to future delivery of projects
Ensure all project documentation, approved plans, agency correspondences, etc. are tracked and maintained in team drives and share sites appropriately
Regulatory (50%)
Comfortable meeting with regulators and managing the program relationship at the regulator/state agency level - this will require tact, ability to read situations appropriately and make judgment calls about information sharing and problem escalation when necessary
Advise Operations team on regulation interpretations
Provide regulatory support for operations team in CDTB program related inquiries and decision making
Maintain knowledge of DEA, Board of Pharmacy and applicable federal and state disposal regulations regarding Drug Take-Back and state stewardship program laws and regulations
Assist in the regulatory special projects that may include (but not limited to) licensing and policies and procedures
Strategic (20%)
Build relationships with regulatory agencies, clients and internal resources as necessary
Work with internal teams to grow the CDTB Program, sustainability initiatives or other Special Projects
Manage multiple tasks and responsibilities in a fast-paced environment
Required Qualifications:
Bachelor’s Degree in business or related field required
4-6 years of related work experience in project management, utilizing either Agile or Waterfall methodologies; or any equivalent combination of experience and training that provides the required knowledge, skills, and abilities needed to complete the major responsibilities/essentialfunctions of the position. Regulatory experience preferred but not required.
Project Management Professional (PMP) certification a plus
Role requires ability to write professionally with understanding of proper grammar, writing for a professional or governmental audience, and consistent and appropriate use of terminology. Writing samples may be requested.
Excellent verbal communication skills with the ability to communicate with confidence, clarity, and focus; able to convey concepts and considerations to non-technical and technical experts alike
Leadership skills with the ability to collaborate and build relationships across organizations, bridge gaps between teams, and successfully influence without authority
Advanced knowledge/use of Microsoft and Google Suites
Industry experience within regulatory, healthcare, logistics, CPG manufacturer or Retailer, a plus
Individual Competencies:
Integrity: Gains the trust of others by taking responsibility for own actions and telling the truth. Follows through on commitments and agreements; Respects confidentiality; Maintains confidentiality regardless of pressure from others.
Teamwork: Builds relationships and works cooperatively with others, inside and outside the organization, to accomplish objectives to build and maintain mutually beneficial partnerships, leverage information and achieve results.
Establish Focus: The ability to develop and communicate goals in support of the business' mission.
Problem Solving: Gathers and analyzes information to generate and evaluate potential solutions to problems, issues and challenges while weighing the accuracy and relevance of the facts, data and information.
Communication: Giving and receiving messages and information in written, oral, and visual formats concisely for a complete understanding of meaning and intent.
Vision and Strategy: Takes a long-term view and builds a shared vision with others while positioning the organization for future success by identifying new opportunities, formulating objectives and priorities, and implementing plans consistent with the long-term interest of the organization in a global environment.
Business Acumen: Understands and is aware of how to think about and successfully make the right business decisions through the utilization of industry-specific knowledge and skills and strategic thinking tools and skills.
Negotiation: Effectively exploring alternatives and positions to reach outcomes that gain the support and acceptance of all parties.
The physical demands described here are representative of those that must be met by an associate to successfully perform the major job responsibilities (essential functions) of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the major job responsibilities. This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Duties responsibilities and activities may change, or new ones may be assigned at any time with or without notice.
While performing the duties of this job, the associate is:
Regularly required to use hands to finger, handle or feel objects, tools or controls, and reach with hands or arms.
Regularly required to talk or hear and read instructions on a computer monitor and/or printed on paper.
Occasionally required to stand, kneel or stoop, and lift and/or move up to 20 pounds.
Regularly required to view items at an extremely close range and must be able to adjust and readjust focus.
Regularly required to remain in a stationary position.
As an Inmar Associate, you:
Put clients first and consistently display a positive attitude and behaviors that demonstrate an awareness and willingness to listen and respond to clients in order to meet their short-term and long-term needs, requirements and exceed their expectations.
Treat clients and teammates with courtesy, consideration and tact; you also can perceive the needs of internal and external clients and communicate effectively with the objective of delighting and retaining the client.
Build collaborative relationships and work cooperatively with others, inside and outside the organization, to accomplish objectives, develop and maintain mutually beneficial partnerships, leverage information and achieve results.
Set and attain achievable, yet aggressive, goals with a sense of urgency and accountability.
Understand that results are important and focus on turning mission into action to achieve results following the principles of agile, dynamic execution while consistently complying with quality, service and productivity standards to meet deadlines and exceed expectations by giving our clients the best possible outcome.
Support a safe work environment by following safety rules and regulations and reporting all safety hazards.