Regulatory Affairs Specialist

ExelWesterville, OH
294d

About The Position

Deutsche Post DHL (DHL Group) is the logistics provider of the world with over 600,000 employees in more than 220 countries and territories. We are an organization that is not just moving goods around; we have a very clear purpose: Connecting People. Improving Lives. We provide challenges and opportunities for personal and professional development, recognizing the difference you bring to our business. Together, we share the pride of building one of the largest world leaders in logistics and supply chain. DHL Legal Services offers all business partners worldwide solution-oriented legal advice, providing comprehensive support in contracts, negotiations, and processes with customers and suppliers, as well as in general litigation and commercial law matters. In a matrix organization, Legal Services is organized according to regions and global cross-sectional topics. As our business keeps growing, we want you in our AMERICAS region. Ready to immerse yourself in the exciting world of Legal? Join the team and bring your expertise on board! As part of DPDHL, you will be working with a global network of Legal colleagues and benefit from a wide range of development opportunities.

Requirements

  • 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 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.

Nice To Haves

  • 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.
  • Experience working in a matrix organization.
  • Experience working in the Logistics industry.
  • Knowledge of regulations such as FDA GMPs, ATF, DEA and/or others.

Responsibilities

  • Manage planning and coordination of QA/RA licenses, permits, certifications and registrations activities.
  • 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 to ensure compliance, efficiency, and effectiveness.
  • 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 to stay aware of changes impacting current licenses.
  • Maintain proactive interaction with local, state and federal agencies, trade associations, etc.
  • 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 expertise in Pharma, OTC, controlled substances, food, alcohol, and other regulated products managed by DHL.
  • Facilitate establishment, maintenance and continual improvement of the overall RA system.

Benefits

  • 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.

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What This Job Offers

Job Type

Full-time

Industry

Professional, Scientific, and Technical Services

Education Level

Associate degree

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