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Full TimeWesterville, Ohio
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 Servicesoffers 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:
Responsible for Project Management and state and federal regulatory analysis for North America Regulatory Affairs (RA) activities supporting products and services:
- Engagement and issue resolution with State Boards of Pharmacy (BOP), the Food & Drug Administration (FDA), State Departments of Health, the Drug Enforcement Agency (DEA) and State Departments of Agriculture.
- Navigate and provide expert analysis for the very complex nature of the US regulatory landscape for FDA regulated products including food, Prescription (Rx) drugs and medical devices, Over the Counter (OTC) Drugs and devices, Cosmetics, Controlled Substances and Cannabis
- Develop Standard Operating Procedures (SOP’s) to align with state and federal regulatory requirements for the Retail, Consumer, Ecommerce and Life Science sectors.
- Develop processes that ensure compliance to product requirements.
- Develop systematic programs that increase efficiency within the Department while ensuring compliance.
Your tasks:
- Supports Regulatory Director with state and federal regulatory compliance.
- Serves as subject matter expert on product-related regulations, standards, and codes (e.g., FDA, DEA, ATF, BOP, USDA, etc.).
- Interprets regulatory requirements and actions required for compliance.
- Provides leadership and direction to ensure effective implementation, application, and continuous improvement of regulatory activities and ensures alignment and compliance with Global Quality and Regulatory initiatives.
- Advisor to senior management and legal team on regulatory issues/initiatives, including Suspicious Order Monitoring (SOM), Repack and relabel initiatives, new product introductions and the Drug Supply Chain Security Act (DSCSA)
- Provides information, guidance, and recommendations to DSC leadership.
- Provide oversight to operations with implementation and training on RA processes and procedures.
- Verify and analyze regulatory metrics and create executive management reporting.
Your profile:
Education Level
- Bachelor’s degree in engineering or technical discipline
- Quality or Regulatory certifications
- Prior experience with state and federal inspections and audits from BOP, FDA, DEA, etc.
- Hands on technical experience in the medical filed including drug or device operations.
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.