Regulatory Affairs Manager Jobs

About DPDHL and Legal Services:
Deutsche Post DHL (DHL Group) the logistics provider of the world with over 580,000 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.
We are looking for an immediate, full-time, permanent position in AMERICAS at Westerville, Ohio or it can also be REMOTE in the US.
Job Purpose:
Responsible for leadership and continuous improvement of North America Regulatory Affairs (RA) activities supporting products and services:
Manages licensure, permits, certifications, and accreditations
Provides regulatory leadership, strategy, and support
Ensures goals, objectives and execution are aligned with DSC and Sector requirements
Provides information, guidance and recommendations to DSC leadership
Agency and customer interface / liaison for regulatory matters
Consultant to Business Development: provides direction on RA issues related to business pursuits
Your tasks:

• Advisor to Senior Management and Customers on regulatory issues/initiatives, including problem-solving, business pursuits, strategic direction, and significant issues.
• Provide oversight to operations with implementation and training on RA processes and procedures
• Support Project Delivery team with licensing and other regulatory matters required for a successful start-up
• Ensures goals, objectives and execution are aligned with DSC and BU requirements
• Coaching support for site management
• Develop, maintain and continually improve site level training on regulatory, quality and the systems used to deploy training
• Verify and analyze regulatory metrics and create executive management reporting
• Supports and reviews continuous improvement opportunities with regulatory processes for licensure, permits, certifications, and accreditations
• Training & Development: Understands and coach others on processes, tools and standards. Ensures training requirements are met. Identify and address skill gaps.
• Provides information, guidance and recommendations to DSC leadership
• Provides guidance and resources to support operations with external audits from regulators
• Provided direction on regulatory and quality issues related to business pursuits
• Engaged with site level support to quality and operations personnel as required
• Supports Regulatory Director with site compliance with federal and state regulatory requirements. 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.
• Communication & Engagement: Communicates site, company, and other pertinent information to team. Shares customer and DHL Supply Chain information accordingly.
• 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.

Your profile:
Essential

• Presentation and project management skills
• Interpersonal skills with the ability to express an opposing view effectively and diplomatically
• 7+ years of experience in regulatory and quality management preferably managing Pharmaceutical drug, Medical device and food storage and distribution or manufacturing
• Ability to read and interpret technical documents and regulations
• Computer skills, including spreadsheets and word processing using applications such as Microsoft Office for tracking, analyzing, and communicating related data and ability to work with enterprise systems
• Ability to enter and manipulate data to generate reports in a timely manner
• Leadership and influencing skills
• Experience and working knowledge of Quality Assurance principles and methodology
• Ability to be flexible and work effectively (deliver results) with a practical outlook within a dynamic matrix organization with minimal supervision
• Bachelor’s degree in related field
• Excellent verbal and written communication skills, including good facilitation skills

Desired

• MBA or higher level degree
• Operational and Manufacturing experience in the Supply Chain industry
• Quality or Regulatory certified training
• Experience with regulatory licensing, regulatory agencies and quality management/systems, practical application a plus
• Functional expertise in other areas such as continuous improvement, project management, GxP, etc.

We offer:

• Flexibility and great opportunity to learn
• Tempting Compensation and benefits
• Great opportunity to work for the biggest logistics company in the world
• International and virtual environment

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.
Equal Opportunity Employer, Disability/Vets. Click here for EEO Statements and Reasonable Accommodations.