Regulatory Affairs Specialist
- Respond to requests for regulatory licensing support.
- Manage application tracking and associated support to ensure licensing applications are processed in accordance with jurisdictional and quality requirements.
- Communicate policies, requirements and procedures in support of the business
- Function as the primary licensing contact for customers, DHL Supply Chain management and state and federal agencies
- Provide support for the licensing and certifications programs
- Facilitate and ensure licensing is current and compliant with regulatory requirements for all DSC sites and Business Units.
- Develop and maintain tracking tool(s) providing visibility of current status of licenses and license pursuits within the organization.
- Manage subscription management for state and federal background checks. Work proactively with the organization to ensure applications for new licenses, license renewals and Designated Representative (DR) changes are processed in a timely manner.
- Develop and continually improve licensing process and procedures, at all levels, to ensure processes are compliant, efficient and effective. Develop efficient and effective working relationships with other functional areas and personnel supporting the licensing program
- Develop and execute project plans to ensure licenses are obtained for start-ups in alignment with the licensing project plan.
- Implement collaborative processes with operations and the regional QA team and operations to stay aware of changes in organization personnel, structures, addresses and other changes that impact current licenses. Facilitate updates, as necessary, with regulatory agencies to maintain license integrity.
- Maintain proactive interaction with local, state and federal agencies, trade associations, etc. to stay informed of pending and/or new requirements ensuring adequacy of current licensing and that new requirements are properly incorporated in a timely manner.
- Act as advisor to the management team on licensing issues/initiatives.
- Assist QA/RA leadership to develop and implement related training programs for associates.
- Provide other support to QA/RA leadership, as required.
- Develop SM expertise in Pharma, OTC, controlled substances, food, alcohol, and other regulated products managed by DHL. Continue to expand and develop knowledge and expertise to support business expansion
- Facilitate establishment, maintenance and continual improvement of the overall RA system.
- Associate degree or above OR equivalent in a related field of study
- At least three years of relevant experience in a regulated environment
- Direct experience and a background in QA, RA or Legal
- Experience with obtaining licenses, permits, etc.
- Analytical skills and demonstrated history of success in problem solving toward achievement of goals and objectives
- Computer skills in databases, spreadsheets and word processing for Tracking, analyzing and communicating related data.
- Ability to input and manipulate data and create reports, as required, in a timely fashion.
- Good meeting facilitation and presentation skills
- Ability to use good judgment in making decisions, restructuring priorities and adjusting tasks in a dynamic environment
- Able to communicate and establish effective working relationships with associates at all levels of the organization
- Bachelor’s or graduate degree in a related field of study
- Experience in working directly with regulatory agencies
- Basic project management skills
- Basic training skills
- Experienced in working in a matrix organizationExperience working in the Logistics industry
- Knowledge of regulations such as FDA GMPs, ATF, DEA and/or others
- Great opportunity to work for the biggest logistics company in the world
- International and virtual environment
- Flexibility and great opportunity to learn
- Tempting Compensation and benefits
Regulatory Affairs Specialist
Do you enjoy working in a team environment providingRegulatory compliance related support?Do you take an energetic and influential approach to bring challenge and perspective?Do you have a high regard for personal accountability and fully understand why integrity, accurate information, and customer focus are required qualities to display within the over-arching Operational Excellence team?
If so, DHL Supply Chain has the opportunity for you.
Job Description
Help manage planning and coordination of QA/RA licenses, permits, certifications and registrations activities. Respond to requests for regulatory licensing support. Acts as subject matter expert regarding related governmental regulations. Communicate policies, requirements, and procedures in support of the business. Functions as primary licensing contact for customers, DHL Supply Chain management and agencies.
- Facilitate and ensure licensing is current and compliant with regulatory requirements for all DHL Supply Chain sites and Business Units.
- Develop and maintain tracking tool(s) providing visibility of current status of licenses and license pursuits within the organization.
- Manage designated representative communication with state and federal agencies.
- Reconcile license provider invoices and manage financial tracking of renewal licensing costs.
- Work proactively with the organization to ensure applications for new licenses and renewals are processed in a timely manner.
- Develop efficient and effective working relationships with other functional areas and personnel supporting the licensing program.
- Develop and execute project plans to ensure licenses are obtained for start-ups in alignment with the licensing project plan.
- Implement collaborative processes with operations, the regional QA team, and operations to stay aware of changes in organization personnel, structures, addresses, and other changes that impact current licenses.Facilitate updates, as necessary, with regulatory agencies to maintain license integrity.
- Provide Business Development with compliance information and status in support of new business.Interface with customers, as needed, in support.
- Maintain proactive interaction with local, state, and federal agencies, trade associations, etc. to stay informed of pending and/or new requirements ensuring adequacy of current licensing and that new requirements are properly incorporated in a timely manner.
- Act as adviser to the management team on licensing issues.
- Develop, distribute, and maintain management reports.
- Develop SM expertise in Pharma, OTC, controlled substances, food, alcohol, and other regulated products managed by DHL.Continue to expand and develop knowledge and expertise to support business expansion.
- Facilitate establishment, maintenance, and continual improvement of the overall RA system.
- Provide other support to QA/RA leadership as required.
Required Education and Experience
- Associate's degree in business or field related, required
- Bachelor's degree in business or field related, preferred
- 2+ years experience in a regulated environment, required
- Experience with obtaining license, permits, etc. and/or working with regulatory agencies, preferred
Our Organization has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.
Our Organization is an equal opportunity employer.
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