What are the responsibilities and job description for the Regulatory Affairs Specialist position at DHL?
About DPDHL and Legal Services:
Deutsche Post DHL (DHL Group) 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, and we are: Connecting People. Improving Lives. We provide challenges and opportunities for personal and professional development, we recognize the difference you bring to our business and 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. We provide 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 on the one hand according to regions and on the other hand according to 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.
Job Purpose:
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
Your tasks:
- 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.
Your profile:
Essentials
- 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
Desired
- 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
We offer:
- 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
DHL is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here: https://www.eeoc.gov/employers/eeo-law-poster
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
